Osteoarthritis, KneeNCT00679120
Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types
A study testing Oxford Uni Knee in people with Osteoarthritis, Knee, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Oxford Uni Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis
- Patients found suitable for UKA with telos stress-radiographs
- Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis
- Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint
- Patients can only take part in one knee study
- All age groups, in good condition and responsible adults
- Informed, written compliance consent.
Who cannot join
- Patients with neuromuscular or vascular diseases in the affected leg
- Patients found to be unsuitable for UKA before or at surgery
- Preoperative extensions defect greater than 10 degrees
- Preoperative maximal flection of less than 100 degrees
- Symptomatic patellofemoral osteoarthritis
- Insufficiency with regard to ACL
Show all 26Show fewer
- Patients templated to a size XS or XL femoral component prior to surgery.
- Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis
- Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5
- Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures)
- Patients previous having PTO or other extensive knee surgery
- Patients with metabolic bone disease
- Patients with rheumatoid arthritis
- Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment)
- Patients who intermittently or continuously require treatment with systemic glucocorticoids
- Non-Danish citizens
- Insufficient command of the Danish language (read and speak)
- Senile dementia
- Misuse of drugs or Alcohol
- Serious psychiatric illness
- Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy
- Serious systemic disease (e.g.. hemiparesis and severe Parkinsonism)
- Systemic hip or back condition
- Employed by the department of orthopaedic surgery
- On-going case involving work injury of the knee
- Patients with poor dental status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types.
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees.
Read the detailed description
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a series of three different Oxford Uni Knees by studying:
- Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed).
- Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
- Changes in periprosthetic bone mineral density between the three randomized groups evaluated in the proximal tibia and distal femur on the surgical side and on the unaffected tibial condyle area (BMD).
- Clinical function of the Uni Knee evaluated by a score system using a recent Danish adaptation of the Oxford Knee Score that consists of a questionnaire filled-out by the patient with 12 simple questions on pre-and postoperative assessment of the ADL.
- Analysis of wear of the mobile polyethylene (meniscus) including a methodical study as to whether the technique requires weightbearing (standing) stereoroentgenograms or whether non-weightbearing stereoroentgenograms can be used (assessed with Model Based RSA).
- If a fast bone-remodeling increases the risk of aseptic loosening (histomorphometric results combined with RSA results and possible revision)
- Increased risk of aseptic loosening with cemented (two designs) compared to uncemented im-plants.
- If bone-remodeling of the proximal tibia is dependent on gender and age.
The study would be considered a success if all designs of the prostheses are firmly fixed and remain so during the entire period of study, that is, no increasing migration is seen using RSA. It would be a success if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration.
The hypotheses are:
- RLL in relation to the tibial component is unimportant for fixation of the Oxford Uni Knee as assessed with DEXA and RSA.
- There is very little wear of the polyethylene in the course of a 5 year follow-up as assessed with RSA.
- The femoral component is expected to remain fixed throughout the entire period of follow-up.
- Function assessment as ROM (range of motion) after UKA is satisfactory and generally better than after TKA.
- All three prosthetic designs are expected to migrate minimally and remain fixed throughout the follow-up period, but the uncemented design is expected to be superior to the cemented design.
- No difference in clinical outcome between the three prosthetic types.
- The bone-remodeling rate in the medial periarticular tibia bone increases the risk of aseptic loosening.
The primary parameters of effect are RLL, RSA and DEXA. The secondary parameters of effect are bone-remodeling, wear analysis, Oxford Knee Score (ADL) and ROM.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Oxford Uni Knee
- Keywords
- Unicompartmental osteoarthrosis, RSA, Bone-remodelling
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford Uni KneeDevice
Also called Biomet, Oxford Uni Knee, single pegged femur, Biomet, Oxford Uni Knee,standard tibial bearing tray
Oxford Uni Knee inserted at the time of surgery
Oxford Uni KneeDevice
Also called Biomet, Oxford Uni Knee, twin pegged femur, Biomet, Oxford Uni Knee, standard tibial bearing tray
Oxford Uni Knee inserted at the time of surgery
Oxford Uni KneeDevice
Also called Biomet, Oxford Uni Knee, cementless femur, Biomet, Oxford Uni Knee, cementless tibial bearing tray
Oxford Uni Knee inserted at the time of surgery (porous coated and HA coated)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Cemented single pegged femur with standard tibial bearing tray Receives: Device: Oxford Uni Knee |
| 2 | Active comparator | Cemented twin pegged femur with standard tibial bearing tray Receives: Device: Oxford Uni Knee |
| 3 | Active comparator | Cementless tibial bearing tray and femur (porous coated and HA coated) Receives: Device: Oxford Uni Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed)
Measured: 2016
Secondary outcomes (1)
Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
Measured: 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMay 2009
- Primary completionOct 2017
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, MD, Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679120
- Sponsor's protocol ID
- 20070258
- Status last verified
- Dec 2022
- First submitted
- 14 May 2008
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.
PubMed 36422666
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types.
- ClinicalTrials.gov ID
- NCT00679120
- Acronym / sponsor ID
- 20070258
- Conditions
- Osteoarthritis, Knee
- Keywords
- Unicompartmental osteoarthrosis, RSA, Bone-remodelling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Zimmer Biomet
- Study start
- May 2009 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees.
Detailed description
The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a series of three different Oxford Uni Knees by studying:
- Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed).
- Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
- Changes in periprosthetic bone mineral density between the three randomized groups evaluated in the proximal tibia and distal femur on the surgical side and on the unaffected tibial condyle area (BMD).
- Clinical function of the Uni Knee evaluated by a score system using a recent Danish adaptation of the Oxford Knee Score that consists of a questionnaire filled-out by the patient with 12 simple questions on pre-and postoperative assessment of the ADL.
- Analysis of wear of the mobile polyethylene (meniscus) including a methodical study as to whether the technique requires weightbearing (standing) stereoroentgenograms or whether non-weightbearing stereoroentgenograms can be used (assessed with Model Based RSA).
- If a fast bone-remodeling increases the risk of aseptic loosening (histomorphometric results combined with RSA results and possible revision)
- Increased risk of aseptic loosening with cemented (two designs) compared to uncemented im-plants.
- If bone-remodeling of the proximal tibia is dependent on gender and age.
The study would be considered a success if all designs of the prostheses are firmly fixed and remain so during the entire period of study, that is, no increasing migration is seen using RSA. It would be a success if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration.
The hypotheses are:
- RLL in relation to the tibial component is unimportant for fixation of the Oxford Uni Knee as assessed with DEXA and RSA.
- There is very little wear of the polyethylene in the course of a 5 year follow-up as assessed with RSA.
- The femoral component is expected to remain fixed throughout the entire period of follow-up.
- Function assessment as ROM (range of motion) after UKA is satisfactory and generally better than after TKA.
- All three prosthetic designs are expected to migrate minimally and remain fixed throughout the follow-up period, but the uncemented design is expected to be superior to the cemented design.
- No difference in clinical outcome between the three prosthetic types.
- The bone-remodeling rate in the medial periarticular tibia bone increases the risk of aseptic loosening.
The primary parameters of effect are RLL, RSA and DEXA. The secondary parameters of effect are bone-remodeling, wear analysis, Oxford Knee Score (ADL) and ROM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Oxford Uni KneeCemented single pegged femur with standard tibial bearing tray |
| 2 | Active comparator | Device: Oxford Uni KneeCemented twin pegged femur with standard tibial bearing tray |
| 3 | Active comparator | Device: Oxford Uni KneeCementless tibial bearing tray and femur (porous coated and HA coated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis
- Patients found suitable for UKA with telos stress-radiographs
- Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis
- Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint
- Patients can only take part in one knee study
Key exclusion criteria (26 listed)
- Patients with neuromuscular or vascular diseases in the affected leg
- Patients found to be unsuitable for UKA before or at surgery
- Preoperative extensions defect greater than 10 degrees
- Preoperative maximal flection of less than 100 degrees
- Symptomatic patellofemoral osteoarthritis
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 |
|---|---|---|
| Oxford Uni KneeAlso: Biomet, Oxford Uni Knee, single pegged femur, Biomet, Oxford Uni Knee,standard tibial bearing trayOxford Uni Knee inserted at the time of surgery | Device | 1 |
| Oxford Uni KneeAlso: Biomet, Oxford Uni Knee, twin pegged femur, Biomet, Oxford Uni Knee, standard tibial bearing trayOxford Uni Knee inserted at the time of surgery | Device | 2 |
| Oxford Uni KneeAlso: Biomet, Oxford Uni Knee, cementless femur, Biomet, Oxford Uni Knee, cementless tibial bearing trayOxford Uni Knee inserted at the time of surgery (porous coated and HA coated) | Device | 3 |
Primary outcome
Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed)
Time frame: 2016
1 secondary outcome
Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and "overhang" of the tibial trays.
Time frame: 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 36422666Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.
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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.
Kjeld Soballe, MD, Prof. principal investigator
Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford Uni Knee in people with Osteoarthritis, Knee, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed) (time frame: 2016). 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 NCT00679120, which also lists 1 linked publication.
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 22 Nov 2023.