Total Knee ArthroplastyPhase 4NCT01483066
Clinical Outcomes and Cost-effectiveness Analysis of ShapeMatch Technology
A Phase 4 study testing ShapeMatch Technology in people with Total Knee Arthroplasty, run by University of Alberta at 1 site in Canada.
Trial summary
The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- ShapeMatch Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to 26 Jun 2015
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a male or non-pregnant female age 18 to 80 years of age at the time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for a primary total knee replacement (TKR).
- Patient is willing and able to comply with preoperative Magnetic Resonance Imaging (MRI) requirements, postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has a varus or valgus deformity greater than 10 degrees or flexion contracture greater than 20o.
- Patient has an active or suspected latent infection in or about the affected joint at time of study device implantation.
- Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
- Patient requires bilateral TKR, or has had a contralateral partial TKR or TKR.
- Patient has any implanted device that would be incompatible with MRI procedures.
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- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements(e.g. > 30 days).
- Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
- Patient has a known sensitivity to device materials.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services - Edmonton zone
Edmonton, Alberta, TG6 2B7
About this study
Official title: A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology
The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral head and talus. Standard surgical technique typically involves femoral and tibial rods with cutting blocks to facilitate the intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. The surgeon can then assess implant placement and adjust as necessary during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better control over the placement of the implants.
This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.
Read more
One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to reproduce the natural kinematic alignment of the knee. The other half of the cases will receive the Triathlon® CR device in a procedure using traditional instrumentation, without navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and 2 years postoperatively.
Primary Hypothesis:
The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.
Secondary Hypotheses:
The investigators expect that ShapeMatch Technology will result in improved clinical outcomes relative to usual care at three months postoperatively.
The investigators expect that ShapeMatch Technology will result in similar clinical outcomes relative to usual care at two-years postoperatively.
- Conditions
- Total Knee Arthroplasty
- Being tested
- ShapeMatch Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShapeMatch TechnologyDevice
ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.
| Study group | Role | What they receive |
|---|---|---|
| ShapeMatch Instrumentation | Experimental | Not described Receives: Device: ShapeMatch Technology |
| Usual Instrumentation | Active comparator | Not described Receives: Device: ShapeMatch Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness analysis (CEA)
The CEA will examine the cost of health care resources and health outcomes from the surgical intervention to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the surgery and adverse events of the surgery will be the basis of a sensitivity analysis.
Quality adjusted life years (QALYs) is the preferred measure for CEA. QALYs will be calculated based on the EuroQol-5D (EQ-5D). An objective outcome measure may be used for additional analysis.
Measured: surgery to one year postoperatively
Secondary outcomes (4)
Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is an instrument used to assess the patient's opinion about his or her knee and associated problems and has been validated for use in this population.
Measured: preoperative - 2 years postoperative
EuroQol-5D (EQ-5D)
The EQ-5D is a generic health status questionnaire that will be used to measure overall health status and will be used in the CEA.
Measured: preoperative to 2-years postoperative
University of California at Los Angeles (UCLA) Activity Scale
The UCLA activity score is a self-administered patient evaluation designed to reflect patient activity.
Measured: preoperative to 2-years postoperative
Forgotten Joint Score
The Forgotten Joint Score is a recently developed tool that examines how aware the subject is of their TKR during activities of daily living.
Measured: Imediate postoperative to 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startJun 2012
- Primary completion26 Jun 2015
- Study completion26 Jun 2015
Why it stopped: FDA recall - Canadian system did voluntary suspension of study; Investigators subsequently decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Canada LP
- Responsible party
- Sponsor
- Investigators
- Gordon Arnett, MD, FRCS (C), Principal investigator, Alberta Health servicesLauren Beaupre, PT, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483066
- Sponsor's protocol ID
- Pro00024283
- Status last verified
- Jul 2021
- First submitted
- 25 Nov 2011
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology
- ClinicalTrials.gov ID
- NCT01483066
- Acronym / sponsor ID
- Pro00024283
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA recall - Canadian system did voluntary suspension of study; Investigators subsequently decided to terminate the study
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Stryker Canada LP
- Study start
- Jun 2012
- Primary completion
- 26 Jun 2015 (actual)
- Study completion
- 26 Jun 2015 (actual)
- First posted
- 1 Dec 2011 (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 currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral head and talus. Standard surgical technique typically involves femoral and tibial rods with cutting blocks to facilitate the intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. The surgeon can then assess implant placement and adjust as necessary during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better control over the placement of the implants.
This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.
One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to reproduce the natural kinematic alignment of the knee. The other half of the cases will receive the Triathlon® CR device in a procedure using traditional instrumentation, without navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and 2 years postoperatively.
Primary Hypothesis:
The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.
Secondary Hypotheses:
The investigators expect that ShapeMatch Technology will result in improved clinical outcomes relative to usual care at three months postoperatively.
The investigators expect that ShapeMatch Technology will result in similar clinical outcomes relative to usual care at two-years postoperatively.
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 |
|---|---|---|
| ShapeMatch Instrumentation | Experimental | Device: ShapeMatch Technology |
| Usual Instrumentation | Active comparator | Device: ShapeMatch Technology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is a male or non-pregnant female age 18 to 80 years of age at the time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for a primary total knee replacement (TKR).
- Patient is willing and able to comply with preoperative Magnetic Resonance Imaging (MRI) requirements, postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (11 listed)
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has a varus or valgus deformity greater than 10 degrees or flexion contracture greater than 20o.
- Patient has an active or suspected latent infection in or about the affected joint at time of study device implantation.
- Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
- Patient requires bilateral TKR, or has had a contralateral partial TKR or TKR.
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 |
|---|---|---|
| ShapeMatch TechnologyShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. | Device | ShapeMatch Instrumentation, Usual Instrumentation |
Primary outcome
Cost-effectiveness analysis (CEA)
Time frame: surgery to one year postoperatively
The CEA will examine the cost of health care resources and health outcomes from the surgical intervention to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the surgery and adverse events of the surgery will be the basis of a sensitivity analysis. Quality adjusted life years (QALYs) is the preferred measure for CEA. QALYs will be calculated based on the EuroQol-5D (EQ-5D). An objective outcome measure may be used for additional analysis.
4 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: preoperative - 2 years postoperative
EuroQol-5D (EQ-5D)
Time frame: preoperative to 2-years postoperative
University of California at Los Angeles (UCLA) Activity Scale
Time frame: preoperative to 2-years postoperative
Forgotten Joint Score
Time frame: Imediate postoperative to 2 years postoperative
Results and safety
The study was stopped early (reason given: FDA recall - Canadian system did voluntary suspension of study; Investigators subsequently decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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.
Gordon Arnett, MD, FRCS (C) principal investigator
Alberta Health services
Lauren Beaupre, PT, PhD study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ShapeMatch Technology in people with Total Knee Arthroplasty, run by University of Alberta 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Jul 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: FDA recall - Canadian system did voluntary suspension of study; Investigators subsequently decided to terminate the 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?
Cost-effectiveness analysis (CEA) (time frame: surgery to one year postoperatively). 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 28 Jul 2021.