OsteoarthritisNCT01262430
Application of Radiostereometric Analysis (RSA) to Triathlon Knee Components Inserted Using the OtisMed Custom-fit Total Knee Replacement System
A study testing OtisMed and Computer Assisted Surgery (CAS) in people with Osteoarthritis, run by Dalhousie University at 1 site in Canada.
Trial summary
The OtisMed Custom-fit system for total knee replacements replaces conventional surgical techniques for templating and intra-operative instrumentation with a preoperative virtual surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT image. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- OtisMed and Computer Assisted Surgery (CAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Dec 2019
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Who cannot join
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
Show all 13Show fewer
- Leg length discrepancy greater than 10 mm
- Pregnancy
- Active or prior infection
- Morbid Obesity (BMI > 40)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial Using RSA to Compare the OtisMed Customfit Total Knee Replacement Procedure With Computer Assisted Surgery
The OtisMed Custom-fit system for total knee replacements replaces conventional surgical techniques for templating and intra-operative instrumentation with a preoperative virtual surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT image. The 3D model of the affected knee is processed with a proprietary algorithm that virtually alters it to its pre-arthritic state by filling articular defects, removing osteophytes, and approximating the joint surface. The software then shape matches the knee replacement femoral and tibial components to the preathritic knee model and aligns the femoral component to the functional flexion-extension axis of the femur. The final preoperative step is the machining of custom biocompatible plastic cutting blocks that fit the arthritic knee. These cutting blocks are used during the knee replacement surgery to guide the bone cuts so that the replacement components are aligned for the individual patient.
In this study we propose to compare patients who have received total knee replacement components with the OtisMed Custom-fit procedure to those who have had the same components implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery. Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone mineral density, full leg alignment, change in intra-operative frontal plane alignment, intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number of instrument pans used, and length of hospital stay.
Read the detailed description
Knee and hip arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a knee or hip arthroplasty is finite. This fact has largely been responsible for the continued development of new devices and techniques for joint arthroplasty surgery.
The OtisMed Custom-fit technique has great potential to shift knee replacement surgery to a more patient-specific paradigm. Existing studies with OtisMed surgeries have found a reduced need for soft-tissue releases, alignment comparable to conventional and computer navigated surgery, reduced tourniquet time, and reduced instrumentation. Although the preliminary results are promising the OtisMed Custom-fit system is still unproven, with no long-term follow-up studies completed to date. An initial report has questioned the effectiveness of the procedure although it is a very limited series of four surgeries. To definitively determine if the technique is an improvement on conventional knee arthroplasty a randomized controlled trial with high-resolution quantitative assessment of outcomes is clearly called for.
Question 1: Is there a difference in micromotion patterns for implant components between CAS and the OtisMed knee system?
- Null Hypothesis: There are no significant difference in micromotion patterns.
- Alternative Hypothesis: There are significant differences in micromotion patterns between the tibial and/or femoral components.
Question 2: Do the CAS knee components achieve adequate fixation to the underlying bone?
- Null Hypothesis: There is no significant continuous migration of the tibial and femoral components at 2 years indicating adequate long-term fixation at the implant - bone interface.
- Alternative Hypothesis: There is significant continuous migration of the tibial and/or femoral components at 2 years indicating inadequate fixation at the implant - bone interface.
Question 3: Do the OtisMed knee components achieve adequate fixation to the underlying bone?
- Null Hypothesis: There is no significant continuous migration of the tibial and femoral components at 2 years indicating adequate long-term fixation at the implant - bone interface.
- Alternative Hypothesis: There is significant continuous migration of the tibial and/or femoral components at 2 years indicating inadequate fixation at the implant - bone interface.
Question 4: For what proportion of implants in each group does migration continue to increase during the two year follow-up?
Question 5: Are inducible displacements, measured during loaded follow-up exams, different between the 2 groups?
Question 6: Are there significant differences in bone mineral density between the operative knee (proximal tibia) and other body sites over time?
Question 7: Are there significant differences in bone mineral density of the proximal tibia between the OtisMed and CAS groups over time?
Question 8: Is there a significant difference in gait symmetry measures, health status and functional outcome between the OtisMed and CAS groups?
Question 9: Is there a significant difference in postoperative full-leg length alignment between the CAS and OtisMed groups?
Question 10: Are there significant differences in the frontal plane alignment curves obtained from the CAS system between the CAS and OtisMed groups?
Question 12: Are there significant differences in the quantity of bone resection between the CAS and OtisMed groups?
Question 13: Are there significant differences in the frontal plane alignment curves obtained from the CAS system between the CAS and OtisMed groups?
Question 14: Are there significant differences in the number of intra-operative deviations from the surgical plan between the CAS and OtisMed groups?
Question 15: Is there a significant difference in the duration of surgery (tourniquet time) between the CAS and OtisMed groups?
Question 16: Is there a significant difference in the number of instrument pans used between the CAS and OtisMed groups?
Question 17: Is there a significant difference in length of hospital stay between the CAS and OtisMed groups?
Question 18: Are there intra-patient differences between the OtisMed surgical plan and the CAS surgical procedure in terms of predicted versus actual resection and alignment?
- Conditions
- Osteoarthritis
- Being tested
- OtisMed, Computer Assisted Surgery (CAS)
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtisMedProcedure or surgery
Also called Styrker OtisMed Custom-fit Shapematching Guides
OtisMed Custom-fit Shapematching Guides
Computer Assisted Surgery (CAS)Procedure or surgery
Also called Stryker precisioN Knee Navigation System
Stryker Navigation System
| Study group | Role | What they receive |
|---|---|---|
| OtisMed | Active comparator | Not described Receives: Procedure: OtisMed |
| Computer Assisted Surgery (CAS) | Active comparator | Not described Receives: Procedure: Computer Assisted Surgery (CAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA migration
Measured: 2 years
Secondary outcomes (4)
RSA inducible displacement
Measured: 1 year
Questionnaires
Measured: 2 years
DEXA
Measured: 2 years
Gait Analysis (accelerometric)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dunbar, Dalhousie University
- Investigators
- Michael Dunbar, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262430
- Sponsor's protocol ID
- CDHA-RS/2011-296
- Status last verified
- Aug 2020
- First submitted
- 10 Dec 2010
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Using RSA to Compare the OtisMed Customfit Total Knee Replacement Procedure With Computer Assisted Surgery
- ClinicalTrials.gov ID
- NCT01262430
- Acronym / sponsor ID
- CDHA-RS/2011-296
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Dec 2010 (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 OtisMed Custom-fit system for total knee replacements replaces conventional surgical techniques for templating and intra-operative instrumentation with a preoperative virtual surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT image. The 3D model of the affected knee is processed with a proprietary algorithm that virtually alters it to its pre-arthritic state by filling articular defects, removing osteophytes, and approximating the joint surface. The software then shape matches the knee replacement femoral and tibial components to the preathritic knee model and aligns the femoral component to the functional flexion-extension axis of the femur. The final preoperative step is the machining of custom biocompatible plastic cutting blocks that fit the arthritic knee. These cutting blocks are used during the knee replacement surgery to guide the bone cuts so that the replacement components are aligned for the individual patient.
In this study we propose to compare patients who have received total knee replacement components with the OtisMed Custom-fit procedure to those who have had the same components implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery. Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone mineral density, full leg alignment, change in intra-operative frontal plane alignment, intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number of instrument pans used, and length of hospital stay.
Detailed description
Knee and hip arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a knee or hip arthroplasty is finite. This fact has largely been responsible for the continued development of new devices and techniques for joint arthroplasty surgery.
The OtisMed Custom-fit technique has great potential to shift knee replacement surgery to a more patient-specific paradigm. Existing studies with OtisMed surgeries have found a reduced need for soft-tissue releases, alignment comparable to conventional and computer navigated surgery, reduced tourniquet time, and reduced instrumentation. Although the preliminary results are promising the OtisMed Custom-fit system is still unproven, with no long-term follow-up studies completed to date. An initial report has questioned the effectiveness of the procedure although it is a very limited series of four surgeries. To definitively determine if the technique is an improvement on conventional knee arthroplasty a randomized controlled trial with high-resolution quantitative assessment of outcomes is clearly called for.
Question 1: Is there a difference in micromotion patterns for implant components between CAS and the OtisMed knee system?
- Null Hypothesis: There are no significant difference in micromotion patterns.
- Alternative Hypothesis: There are significant differences in micromotion patterns between the tibial and/or femoral components.
Question 2: Do the CAS knee components achieve adequate fixation to the underlying bone?
- Null Hypothesis: There is no significant continuous migration of the tibial and femoral components at 2 years indicating adequate long-term fixation at the implant - bone interface.
- Alternative Hypothesis: There is significant continuous migration of the tibial and/or femoral components at 2 years indicating inadequate fixation at the implant - bone interface.
Question 3: Do the OtisMed knee components achieve adequate fixation to the underlying bone?
- Null Hypothesis: There is no significant continuous migration of the tibial and femoral components at 2 years indicating adequate long-term fixation at the implant - bone interface.
- Alternative Hypothesis: There is significant continuous migration of the tibial and/or femoral components at 2 years indicating inadequate fixation at the implant - bone interface.
Question 4: For what proportion of implants in each group does migration continue to increase during the two year follow-up?
Question 5: Are inducible displacements, measured during loaded follow-up exams, different between the 2 groups?
Question 6: Are there significant differences in bone mineral density between the operative knee (proximal tibia) and other body sites over time?
Question 7: Are there significant differences in bone mineral density of the proximal tibia between the OtisMed and CAS groups over time?
Question 8: Is there a significant difference in gait symmetry measures, health status and functional outcome between the OtisMed and CAS groups?
Question 9: Is there a significant difference in postoperative full-leg length alignment between the CAS and OtisMed groups?
Question 10: Are there significant differences in the frontal plane alignment curves obtained from the CAS system between the CAS and OtisMed groups?
Question 12: Are there significant differences in the quantity of bone resection between the CAS and OtisMed groups?
Question 13: Are there significant differences in the frontal plane alignment curves obtained from the CAS system between the CAS and OtisMed groups?
Question 14: Are there significant differences in the number of intra-operative deviations from the surgical plan between the CAS and OtisMed groups?
Question 15: Is there a significant difference in the duration of surgery (tourniquet time) between the CAS and OtisMed groups?
Question 16: Is there a significant difference in the number of instrument pans used between the CAS and OtisMed groups?
Question 17: Is there a significant difference in length of hospital stay between the CAS and OtisMed groups?
Question 18: Are there intra-patient differences between the OtisMed surgical plan and the CAS surgical procedure in terms of predicted versus actual resection and alignment?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OtisMed | Active comparator | Procedure: OtisMed |
| Computer Assisted Surgery (CAS) | Active comparator | Procedure: Computer Assisted Surgery (CAS) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Key exclusion criteria (13 listed)
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected 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 |
|---|---|---|
| OtisMedAlso: Styrker OtisMed Custom-fit Shapematching GuidesOtisMed Custom-fit Shapematching Guides | Procedure or surgery | OtisMed |
| Computer Assisted Surgery (CAS)Also: Stryker precisioN Knee Navigation SystemStryker Navigation System | Procedure or surgery | Computer Assisted Surgery (CAS) |
Primary outcome
RSA migration
Time frame: 2 years
4 secondary outcomes
RSA inducible displacement
Time frame: 1 year
Questionnaires
Time frame: 2 years
DEXA
Time frame: 2 years
Gait Analysis (accelerometric)
Time frame: 2 years
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 21 Aug 2020.
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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.
Michael Dunbar principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OtisMed and Computer Assisted Surgery (CAS) in people with Osteoarthritis, run by Dalhousie University at 1 site in Canada.
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 3 inclusion and 13 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 21 Aug 2020. 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 Canada. 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?
RSA migration (time frame: 2 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 21 Aug 2020.