Knee OsteoarthritisNCT02845206
Bespoke vs Standard Instrumentation in TKR
A study testing Patient specific cutting blocks and Conventional cutting blocks in people with Knee Osteoarthritis, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient specific cutting blocks and Conventional cutting blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2016to 2 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Who cannot join
- Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity > 5 degrees
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.
This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.
Read the detailed description
Total knee replacement (TKR) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. However, this means that up to 25% of patients are not entirely satisfied with their TKR. The longevity and stability of a TKR is greatly dependent on the accuracy of the initial surgery. Deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'Patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. This will allow for individual bony cuts specific to the patients own anatomy.
'Patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. This could result in improved early range of movement and decreased pain following surgery. The total knee replacement used in this study will be the GMKSphere (Medacta International) TKR. It has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. It may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes.
Patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery.
This study will allow for comparison in knee function and patient outcomes between patients who have undergone their TKR with patient specific cutting blocks compared to conventional cutting blocks. The scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient specific cutting blocks, Conventional cutting blocks
- Keywords
- Total Knee Replacement, Patient Specific Instrumentation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific cutting blocksProcedure or surgery
'MyKnee' Instrumentation
Conventional cutting blocksProcedure or surgery
Standard Instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Patient Specific Cutting Blocks | Experimental | For the bespoke individualised cutting blocks to be manufactured, the patients will undergo a preoperative CT scan under a set protocol. The CT radiation dose will be considerably less than a conventional diagnostic CT scan. Receives: Procedure: Patient specific cutting blocks |
| Conventional Cutting Blocks | Active comparator | The patients in this arm will be operated on using conventional instruments. Receives: Procedure: Conventional cutting blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb alignment
Measured in degrees from Hip-Knee-Ankle radiographs from centre of femoral head to midpoint of the ankle
Measured: 1 years
Secondary outcomes (5)
Difference between baseline pre-op and one year post-op change in gait measured using a bespoke clinic-appropriate motion analysis system.
Knee range of motion, strength and gait analysis assessments will be carried out on a bespoke clinic-appropriate motion analysis system. This system consists of 8 Vicon B10 Bonita cameras (Vicon Systems, Oxford) which immediately surround a self-paced N-Mill treadmill (Motekforce Link, Amsterdam).
Measured: 1 year
Difference in patient reported knee pain level as measured by Oxford Knee Score between baseline and one year and also between study groups.
Validated patient reported knee pain questionnaires as measured by Oxford Knee Score (out of 48 points) pre-operation and at one year post-operation. Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
Measured: 1 year
Difference in patient reported knee function between baseline and one year and also between study groups.
Validated patient reported knee function questionnaires as measured by EQ-5D pre-operation and at one year post-operation. Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
Measured: 1 year
Difference in patient reported quality of life questionnaires between baseline and one year and also between study groups.
Validated quality of life questionnaires as measured by SF-12 score pre-operation and at one year post-operation. Difference between baseline and one year scores for each patient and also analysed between groups (patient specific cutting blocks compared to conventional cutting blocks).
Measured: 1 year
Healthcare cost
Healthcare cost measured in pounds sterling (GBP). Total cost of performing knee replacement using conventional cutting blocks compared to using bespoke cutting blocks and disposable instrumentation. The measurable contributors to the costs of healthcare include operating time (minutes), number of instrument trays requiring sterilisation (number of trays), length of hospital stay (days), patient transfusion requirement (number of units of packed cells required), cost of bespoke disposable instrumentation (GBP).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 Feb 2016
- Primary completion2 Feb 2018
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Leela C Biant, FRCSEd(Tr&Orth) MSres MFSTEd, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845206
- Sponsor's protocol ID
- 15/SS/0058
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2016
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data available to bone fide researchers at the end of the study
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
- Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02845206
- Acronym / sponsor ID
- 15/SS/0058
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Replacement, Patient Specific Instrumentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- NHS LothianOther government
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 27 Jul 2016 (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.
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.
This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.
Detailed description
Total knee replacement (TKR) is an established treatment for 'wear and tear' arthritis and leads to a satisfactory outcome in over 75% of patients. However, this means that up to 25% of patients are not entirely satisfied with their TKR. The longevity and stability of a TKR is greatly dependent on the accuracy of the initial surgery. Deviation of more than 3 degrees from the normal axis can lead to abnormal stresses causing the implants to fail. 'Patient specific' technology involves preoperative computer assessment of the patients' knee and allows for a 'patient specific' cutting block to be manufactured. This will allow for individual bony cuts specific to the patients own anatomy.
'Patient specific' implants and cutting blocks may allow a more optimal implant positioning and are implanted without the need for instrumentation of the femoral medullary canal (thigh), so lower blood loss may result. This could result in improved early range of movement and decreased pain following surgery. The total knee replacement used in this study will be the GMKSphere (Medacta International) TKR. It has a specific design which more closely resembles a natural unreplaced knee than any other knee replacement. It may help address the phenomenon of 'mid flexion instability', which is where the patient perceives their replaced knee to be unsteady on stairs and slopes.
Patient specific technology may also result in a cost saving, as it potentially reduces the number of sterilised trays required during the surgery.
This study will allow for comparison in knee function and patient outcomes between patients who have undergone their TKR with patient specific cutting blocks compared to conventional cutting blocks. The scans obtained following the surgery could lead to world leading methodology for the assessment of knee replacements and would set a blue print for the evaluation of other knee implants in the future.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Specific Cutting Blocks | Experimental | Procedure: Patient specific cutting blocksFor the bespoke individualised cutting blocks to be manufactured, the patients will undergo a preoperative CT scan under a set protocol. The CT radiation dose will be considerably less than a conventional diagnostic CT scan. |
| Conventional Cutting Blocks | Active comparator | Procedure: Conventional cutting blocksThe patients in this arm will be operated on using conventional instruments. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with osteoarthritis ('wear and tear') of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Key exclusion criteria (1 listed)
- Patients with inflammatory arthropathy, patients requiring bone augmentation, ligament incompetence, values deformity > 5 degrees
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 |
|---|---|---|
| Patient specific cutting blocks'MyKnee' Instrumentation | Procedure or surgery | Patient Specific Cutting Blocks |
| Conventional cutting blocksStandard Instrumentation | Procedure or surgery | Conventional Cutting Blocks |
Primary outcome
Limb alignment
Time frame: 1 years
Measured in degrees from Hip-Knee-Ankle radiographs from centre of femoral head to midpoint of the ankle
5 secondary outcomes
Difference between baseline pre-op and one year post-op change in gait measured using a bespoke clinic-appropriate motion analysis system.
Time frame: 1 year
Difference in patient reported knee pain level as measured by Oxford Knee Score between baseline and one year and also between study groups.
Time frame: 1 year
Difference in patient reported knee function between baseline and one year and also between study groups.
Time frame: 1 year
Difference in patient reported quality of life questionnaires between baseline and one year and also between study groups.
Time frame: 1 year
Healthcare cost
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. Data available to bone fide researchers at the end of the study
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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.
Leela C Biant, FRCSEd(Tr&Orth) MSres MFSTEd principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific cutting blocks and Conventional cutting blocks in people with Knee Osteoarthritis, run by NHS Lothian at 1 site in United Kingdom.
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 1 inclusion and 1 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.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Limb alignment (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 28 Oct 2026.