Osteoarthritis, KneeNCT05935878

Cemented Versus Cementless Unicompartmental Knee Arthroplasty

A study testing Cementless Oxford Unicompartmental Knee Arthroplasty and Cemented Oxford Unicompartmental Knee Arthroplasty in people with Osteoarthritis, Knee, run by Oxford University Hospitals NHS Trust.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Cementless Oxford Unicompartmental Knee Arthroplasty and Cemented Oxford Unicompartmental Knee Arthroplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: No sites listed yet
Study dates: 8 Nov 2002to 11 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement.
American Society of Anaesthesiologists (ASA) Score of 1 to 3.

Who cannot join

Subjects with severe limiting systemic illness (i.e. ASA > 3).
Subjects who are too large for radiostereometric analysis to be carried out.
Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.

About this study

Official title: Cemented Versus Cementless Unicompartmental Knee Arthroplasty (UKA) - A Single-blind Randomised Controlled Trial

Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening.

The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.

Read the detailed description

Design: A prospective, randomised trial to compare the outcome of cemented and cementless unicompartmental knee replacement.

Size: 40 subjects in total will be recruited with 20 in each arm.

Methods: Patients will be recruited from the routine waiting list for unicompartmental knee replacement at the Nuffield Orthopaedic Centre. All subjects will have the procedure explained and be fully consented prior to the procedure.

Randomisation: Patients will be randomly allocated to receive either a cemented or cementless Oxford Unicompartmental Knee Replacement. This will be performed using a randomisation program based on optimisation (Minim). Subjects will be stratified according to sex and age.

Operation: All subjects will undergo the same surgical approach. 0.8mm Tantalum marker balls will be placed at standardised sites on the femur and tibia in all cases. All cemented components will be secured using the same cement. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth.

Follow-up: All patients will be followed up at 0, 3, 6, 12, 24, 60, and 120 months with clinical and radiological assessment. Clinical assessment will involve documentation with the Oxford Knee Score. Patients will undergo radiostereometric analysis and fluoroscopy to study implant migration and occurence of radiolucency, respectively.

Conditions: Osteoarthritis, Knee
Being tested: Cementless Oxford Unicompartmental Knee Arthroplasty, Cemented Oxford Unicompartmental Knee Arthroplasty
Keywords: Knee Arthroplasty, Unicompartmental, Fixation, Radiostereometric Analysis
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cementless Oxford Unicompartmental Knee ArthroplastyDevice
Also called Cementless Oxford Unicompartmental Knee Replacement
All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.
Cemented Oxford Unicompartmental Knee ArthroplastyDevice
Also called Cemented Oxford Unicompartmental Knee Replacement
All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.

Study groups in NCT05935878
Study group	Role	What they receive
Cementless Oxford Unicompartmental Knee Arthroplasty	Experimental	Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet) Receives: Device: Cementless Oxford Unicompartmental Knee Arthroplasty
Cemented Oxford Unicompartmental Knee Arthroplasty	Active comparator	Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) Receives: Device: Cemented Oxford Unicompartmental Knee Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral
- Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior
- Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Measured: Patients will be examined 3 months post surgery.
Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral
- Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior
- Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Measured: Patients will be examined 6 months post surgery.
Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral
- Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior
- Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Measured: Patients will be examined 12 months post surgery.
Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral
- Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior
- Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Measured: Patients will be examined 24 months post surgery.
Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres.
Measured: Patients will be examined 60 months post surgery.
Radiostereometric Analysis Examination - Translations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral
- Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior
- Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Measured: Patients will be examined 120 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
*For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
*For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 3 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
- For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 6 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
- For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 12 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
- For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 24 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
- For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 60 months post surgery.
Radiostereometric Analysis Examination - Rotations
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
- For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
- For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Measured: Patients will be examined at 120 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be examined at 3 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be examined at 12 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be examined at 24 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be examined at 60 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be examined at 120 months post surgery.
Radiographic Examination
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Measured: Patients will be examined at 12 months post surgery.
Radiographic Examination
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Measured: Patients will be examined at 24 months post surgery.
Radiographic Examination
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Measured: Patients will be examined at 60 months post surgery.
Radiographic Examination
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Measured: Patients will be examined at 120 months post surgery.
Clinical Assessment
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Measured: Patients will be assessed pre-operatively.
Clinical Assessment
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Measured: Patients will be assessed at 12 months post surgery.
Clinical Assessment
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Measured: Patients will be assessed at 24 months post surgery.
Clinical Assessment
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Measured: Patients will be assessed at 60 months post surgery.
Clinical Assessment
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Measured: Patients will be assessed at 120 months post surgery.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Measured: Patients will be assessed at 6 months post surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 200211 Mar 2022

First posted7 Jul 2023
Study start8 Nov 2002
Primary completion11 Mar 2022
Study completion11 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.
Masking: Single blind
Who is masked: Participant
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05935878
Sponsor's protocol ID: PID7088
Status last verified: Sep 2024
First submitted: 8 Jun 2023
Last updated: 23 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Kendrick BJ, Kaptein BL, Valstar ER, Gill HS, Jackson WF, Dodd CA, Price AJ, Murray DW. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):185-91. doi: 10.1302/0301-620X.97B2.34331.
PubMed 25628280
Campi S, Kendrick BJL, Kaptein BL, Valstar ER, Jackson WFM, Dodd CAF, Price AJ, Murray DW. Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. Knee. 2021 Jan;28:383-390. doi: 10.1016/j.knee.2020.09.003. Epub 2021 Jan 4.
PubMed 33408039

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cemented Versus Cementless Unicompartmental Knee Arthroplasty (UKA) - A Single-blind Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05935878
Acronym / sponsor ID: PID7088
Conditions: Osteoarthritis, Knee
Keywords: Knee Arthroplasty, Unicompartmental, Fixation, Radiostereometric Analysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Oxford University Hospitals NHS TrustUniversity, hospital or other
Study start: 8 Nov 2002 (actual)
Primary completion: 11 Mar 2022 (actual)
Study completion: 11 Mar 2022 (actual)
First posted: 7 Jul 2023 (actual)
Results: Posted 16 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.

Detailed description

Design: A prospective, randomised trial to compare the outcome of cemented and cementless unicompartmental knee replacement.

Size: 40 subjects in total will be recruited with 20 in each arm.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.

Arm	Type	Receives
Cementless Oxford Unicompartmental Knee Arthroplasty	Experimental	Device: Cementless Oxford Unicompartmental Knee ArthroplastyPhase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
Cemented Oxford Unicompartmental Knee Arthroplasty	Active comparator	Device: Cemented Oxford Unicompartmental Knee ArthroplastyPhase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement.
American Society of Anaesthesiologists (ASA) Score of 1 to 3.

Key exclusion criteria (3 listed)

Subjects with severe limiting systemic illness (i.e. ASA > 3).
Subjects who are too large for radiostereometric analysis to be carried out.
Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cementless Oxford Unicompartmental Knee ArthroplastyAlso: Cementless Oxford Unicompartmental Knee ReplacementAll patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.	Device	Cementless Oxford Unicompartmental Knee Arthroplasty
Cemented Oxford Unicompartmental Knee ArthroplastyAlso: Cemented Oxford Unicompartmental Knee ReplacementAll patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.	Device	Cemented Oxford Unicompartmental Knee Arthroplasty

Primary outcome

Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 3 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 6 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 12 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 24 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 60 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres.
Radiostereometric Analysis Examination - Translations
Time frame: Patients will be examined 120 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * X translation: Positive (+ve) = Medial; Negative (-ve) = Lateral * Y translation: Positive (+ve) = Superior; Negative (-ve) = Inferior * Z translation: Positive (+ve) = Anterior; Negative (-ve) = Posterior
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 3 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: *For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus *For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 6 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 12 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 24 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 60 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Rotations
Time frame: Patients will be examined at 120 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: * For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus * For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be examined at 3 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be examined at 12 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be examined at 24 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be examined at 60 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be examined at 120 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.
Radiographic Examination
Time frame: Patients will be examined at 12 months post surgery.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Radiographic Examination
Time frame: Patients will be examined at 24 months post surgery.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Radiographic Examination
Time frame: Patients will be examined at 60 months post surgery.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Radiographic Examination
Time frame: Patients will be examined at 120 months post surgery.
Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'.
Clinical Assessment
Time frame: Patients will be assessed pre-operatively.
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Clinical Assessment
Time frame: Patients will be assessed at 12 months post surgery.
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Clinical Assessment
Time frame: Patients will be assessed at 24 months post surgery.
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Clinical Assessment
Time frame: Patients will be assessed at 60 months post surgery.
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Clinical Assessment
Time frame: Patients will be assessed at 120 months post surgery.
Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
Radiostereometric Analysis Examination - Maximum Total Point Motion
Time frame: Patients will be assessed at 6 months post surgery.
Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres.

Results and safety

Results posted to the registry on 16 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cementless Oxford Unicompartmental Knee Arthroplasty	23	16
Cemented Oxford Unicompartmental Knee Arthroplasty	24	15

Primary outcome: Radiostereometric Analysis Examination - Translations

Time frame: Patients will be examined 3 months post surgery.. Mean (Standard Deviation). Unit: millimetres

Measure	Cementless Oxford Unicompartmental Knee Arthroplasty n = 22	Cemented Oxford Unicompartmental Knee Arthroplasty n = 21
Femoral X Migration	-0.01 (0.36)	0.05 (0.40)
Femoral Y Migration	-0.10 (0.34)	-0.17 (0.25)
Femoral Z Migration	0.26 (0.48)	0.14 (0.33)
Tibial X Migration	-0.09 (0.22)	0.08 (0.28)
Tibial Y Migration	-0.23 (0.18)	-0.10 (0.17)
Tibial Z Migration	-0.03 (0.20)	-0.02 (0.26)

Primary outcome: Radiostereometric Analysis Examination - Translations

Time frame: Patients will be examined 6 months post surgery.. Mean (Standard Deviation). Unit: millimetres

Measure	Cementless Oxford Unicompartmental Knee Arthroplasty n = 22	Cemented Oxford Unicompartmental Knee Arthroplasty n = 21
Femoral X Migration	-0.12 (0.31)	0.05 (0.28)
Femoral Y Migration	-0.02 (0.39)	-0.02 (0.39)
Femoral Z Migration	0.24 (0.39)	0.16 (0.29)
Tibial X Migration	0.06 (0.19)	0.06 (0.19)
Tibial Y Migration	-0.28 (0.17)	0.06 (0.18)
Tibial Z Migration	-0.03 (0.13)	-0.05 (0.30)

Primary outcome: Radiostereometric Analysis Examination - Translations

Time frame: Patients will be examined 12 months post surgery.. Mean (Standard Deviation). Unit: millimetres

Measure	Cementless Oxford Unicompartmental Knee Arthroplasty n = 22	Cemented Oxford Unicompartmental Knee Arthroplasty n = 21
Femoral X Translation	-0.18 (0.28)	0.05 (0.28)
Femoral Y Translation	-0.12 (0.24)	-0.12 (0.25)
Femoral Z Translation	0.26 (0.31)	0.24 (0.32)
Tibial X Translation	-0.04 (0.21)	0.01 (0.24)
Tibial Y Translation	-0.28 (0.19)	-0.09 (0.19)
Tibial Z Translation	-0.01 (0.15)	0.00 (0.26)

Primary outcome: Radiostereometric Analysis Examination - Translations

Time frame: Patients will be examined 24 months post surgery.. Mean (Standard Deviation). Unit: millimetres

Measure	Cementless Oxford Unicompartmental Knee Arthroplasty n = 22	Cemented Oxford Unicompartmental Knee Arthroplasty n = 21
Femoral X Translation	-0.05 (0.53)	0.03 (0.34)
Femoral Y Translation	-0.04 (0.27)	-0.05 (0.32)
Femoral Z Translation	0.21 (0.23)	0.22 (0.42)
Tibial X Translation	0.01 (0.19)	0.06 (0.26)
Tibial Y Translation	-0.34 (0.23)	-0.13 (0.23)
Tibial Z Translation	-0.02 (0.16)	0.03 (0.22)

Adverse events

Time frame: Adverse event data was collected out to 10 years follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cementless Oxford Unicompartmental Knee Arthroplasty	1 of 23 (4.3%)	0 of 23 (0%)	1 of 23
Cemented Oxford Unicompartmental Knee Arthroplasty	1 of 24 (4.2%)	1 of 24 (4.2%)	2 of 24

Limitations and caveats (from the sponsor): At 10 years, loss to follow-up meant there were less than 16 knees in each group required by the power calculation for the study. Maximum Total Point Motion (MTPM) was used as an overall indicator of migration, however the utility of MTPM is limited as it compounds measurement errors so tends to overestimate migration. As the study was powered to detect differences in migration using RSA, the patient numbers were too small to detect differences in clinical outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25628280Kendrick BJ, Kaptein BL, Valstar ER, Gill HS, Jackson WF, Dodd CA, Price AJ, Murray DW. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):185-91. doi: 10.1302/0301-620X.97B2.34331.
Results publication: PubMed 33408039Campi S, Kendrick BJL, Kaptein BL, Valstar ER, Jackson WFM, Dodd CAF, Price AJ, Murray DW. Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. Knee. 2021 Jan;28:383-390. doi: 10.1016/j.knee.2020.09.003. Epub 2021 Jan 4.
Publication of 2-year resultsLink provided by the sponsor.
Abstract of the (partial) 10-year resultsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David W Murray, MA, MD, FRCS principal investigator

University of Oxford

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiostereometric Analysis Examination - Translations (time frame: Patients will be examined 3 months post surgery.). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935878, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.