Osteoarthritis of KneeNCT02577978
Stability of the Medial Pivot Total Knee Prosthesis
A study testing Medacta GMK posterior stabilized prosthesis and Medacta GMK Sphere prosthesis in people with Osteoarthritis of Knee, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare objective and subjective measures of knee stability following total knee arthroplasty with a medial pivot design vs. a posterior stabilized design. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Medacta GMK posterior stabilized prosthesis and Medacta GMK Sphere prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2017
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85, regardless of gender, ethnicity, or pathology
- Must require a total knee arthroplasty
- All subjects must have given signed, informed consent prior to registration in study.
Who cannot join
- Minors
- Any patients that are unable to consent
- Patients with active infection or osseous tumor of the operative extremity
- Patients undergoing revision surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Department of Orthopaedic Surgery
Chicago, Illinois, 60611
About this study
The purpose of this study is to compare objective and subjective measures of knee stability following total knee arthroplasty with a medial pivot design vs. a posterior stabilized design.
Read the detailed description
Several different prostheses are available for use in total knee arthroplasty (TKA). These designs aim to replicate the normal kinematics of the knee joint while maintaining stability throughout a full range of motion. The posterior cruciate ligament (PCL) contributes to these functions in the native knee, and if preserved it can function similarly in the prosthetic knee. Prostheses in which the PCL is sacrificed, and its function not replaced by other means, have poorer outcomes. However, various problems with preserving the PCL, including PCL deterioration in arthritic knees and difficulties with proper tensioning, have led to the development of alternative ways to emulate normal femoral rollback and sagittal plane stability. These posterior-substituted (PS) designs substitute for the PCL with either a cam and post mechanism or a symmetrical ultra-congruent tibial insert.
The cruciate-retaining (CR) and PS designs, together with advances in surgical techniques and component materials, have achieved excellent implant survivorship with rates of > 90% at 20 years. Reports of functional outcomes, however, have been variable. One potential area for improvement in TKA is optimization of implant design to better approximate native knee kinematics. In the normal knee, the medial condyle remains stable in the sagittal plane, functioning like a ball-and-socket, whereas the lateral condyle translates anterior to posterior during flexion. The designs of the CR and PS knees do not allow for this medial-centered rotation. Analysis has revealed paradoxical anterior sliding of the femur during flexion, abnormal axial rotation, and condylar lift-off. Edge loading and increased sagittal plane motion may predispose to accelerated polyethylene wear. The posterior stabilized design uses a cam-and-post mechanism in which one piece of the prosthesis has a plastic post that fits into a slot in the other piece of the prosthesis.
A newer design that attempts to address these issues is the medial pivot knee (MP). This design is characterized by an asymmetrical tibial insert in which the medial compartment is ultra-congruent, providing antero-posterior stability and the lateral compartment allows for rollback around a medial axis of rotation i.e uses a ball-and-socket mechanism. This design more accurately recreates normal knee kinematics, reduces anteroposterior instability, and avoids condylar lift-off. Early studies indicate improved polyethylene wear characteristics. Midterm studies report excellent implant survivorship and clinical outcomes.
Several randomized trials have compared the MP knee favorably with other designs. Patients with bilateral TKAs with a different prosthesis on each side preferred their medial pivot knee to a PS, CR, or mobile-bearing (MB) design. A trial comparing the MP and PS designs found greater range of motion (ROM) and better patient-reported outcomes in the MP group at 2 years. There also exists literature reporting poorer outcomes with the MP design. A trial involving 96 patients who had received both an MP knee and an MB knee on contralateral sides found lower ROM, higher complication rates, and worse patient reported outcomes in the MP knee.
Given the lack of consensus in the literature, further investigation is warranted to determine the impact of the MP design on outcomes following TKA.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Medacta GMK posterior stabilized prosthesis, Medacta GMK Sphere prosthesis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medacta GMK posterior stabilized prosthesisDevice
Medacta GMK Sphere prosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Medacta Sphere | Other | Ball-and-socket Receives: Device: Medacta GMK Sphere prosthesis |
| Medacta PS | Other | Cam-and-post Receives: Device: Medacta GMK posterior stabilized prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
Patient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)
Measured: Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (MCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved physical wellness/function as reported by patients.
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain an increased value indicates greater severity/frequency of pain reported by the patient.
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain an increased value indicates greater severity/frequency of pain reported by the patient
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life
Patient completed questionnaire used to assess the patients' ability to forget about a joint as a result of successful treatment. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60 where a high score indicates an improved outcome. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score with higher scores indicating improved physical function/reduced impact of symptoms on activity:
Final score = 100 - ((sum(item01 to item12) - 12)/48*100)
Measured: 12 months post-operatively
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
The International Knee Documentation Committe (IKDC) Questionnaire is a subjective scale that provides patients with an overall function score based on a summative score for 3 sub categories (knee function, sports activities, pain/symptoms). A score between 0-100 is obtained as the sum of scores for each individual question, with increasing composite scores correlating positively with patient functional status/quality of life.
Measured: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively
Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
Measured: 12 months post-operatively
Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively
Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
Measured: 12 months post-operatively
Secondary outcomes (3)
Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees)
Used for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (>10 mm)
Measured: 1 year post-operatively
Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees)
Used for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (>10 mm)
Measured: 1 year post-operatively
Get-up-and-Go Test
Used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.
Measured: Between 6 months and 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2017
- Study completionJun 2017
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.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Manning, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577978
- Sponsor's protocol ID
- STU00090745
- Status last verified
- May 2023
- First submitted
- 13 Oct 2015
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of the Medial Pivot Total Knee Prosthesis
- ClinicalTrials.gov ID
- NCT02577978
- Acronym / sponsor ID
- STU00090745
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 29 May 2019
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 study is to compare objective and subjective measures of knee stability following total knee arthroplasty with a medial pivot design vs. a posterior stabilized design.
Detailed description
Several different prostheses are available for use in total knee arthroplasty (TKA). These designs aim to replicate the normal kinematics of the knee joint while maintaining stability throughout a full range of motion. The posterior cruciate ligament (PCL) contributes to these functions in the native knee, and if preserved it can function similarly in the prosthetic knee. Prostheses in which the PCL is sacrificed, and its function not replaced by other means, have poorer outcomes. However, various problems with preserving the PCL, including PCL deterioration in arthritic knees and difficulties with proper tensioning, have led to the development of alternative ways to emulate normal femoral rollback and sagittal plane stability. These posterior-substituted (PS) designs substitute for the PCL with either a cam and post mechanism or a symmetrical ultra-congruent tibial insert.
The cruciate-retaining (CR) and PS designs, together with advances in surgical techniques and component materials, have achieved excellent implant survivorship with rates of > 90% at 20 years. Reports of functional outcomes, however, have been variable. One potential area for improvement in TKA is optimization of implant design to better approximate native knee kinematics. In the normal knee, the medial condyle remains stable in the sagittal plane, functioning like a ball-and-socket, whereas the lateral condyle translates anterior to posterior during flexion. The designs of the CR and PS knees do not allow for this medial-centered rotation. Analysis has revealed paradoxical anterior sliding of the femur during flexion, abnormal axial rotation, and condylar lift-off. Edge loading and increased sagittal plane motion may predispose to accelerated polyethylene wear. The posterior stabilized design uses a cam-and-post mechanism in which one piece of the prosthesis has a plastic post that fits into a slot in the other piece of the prosthesis.
A newer design that attempts to address these issues is the medial pivot knee (MP). This design is characterized by an asymmetrical tibial insert in which the medial compartment is ultra-congruent, providing antero-posterior stability and the lateral compartment allows for rollback around a medial axis of rotation i.e uses a ball-and-socket mechanism. This design more accurately recreates normal knee kinematics, reduces anteroposterior instability, and avoids condylar lift-off. Early studies indicate improved polyethylene wear characteristics. Midterm studies report excellent implant survivorship and clinical outcomes.
Several randomized trials have compared the MP knee favorably with other designs. Patients with bilateral TKAs with a different prosthesis on each side preferred their medial pivot knee to a PS, CR, or mobile-bearing (MB) design. A trial comparing the MP and PS designs found greater range of motion (ROM) and better patient-reported outcomes in the MP group at 2 years. There also exists literature reporting poorer outcomes with the MP design. A trial involving 96 patients who had received both an MP knee and an MB knee on contralateral sides found lower ROM, higher complication rates, and worse patient reported outcomes in the MP knee.
Given the lack of consensus in the literature, further investigation is warranted to determine the impact of the MP design on outcomes following TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medacta Sphere | Other | Device: Medacta GMK Sphere prosthesisBall-and-socket |
| Medacta PS | Other | Device: Medacta GMK posterior stabilized prosthesisCam-and-post |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-85, regardless of gender, ethnicity, or pathology
- Must require a total knee arthroplasty
- All subjects must have given signed, informed consent prior to registration in study.
Key exclusion criteria (4 listed)
- Minors
- Any patients that are unable to consent
- Patients with active infection or osseous tumor of the operative extremity
- Patients undergoing revision surgery
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 |
|---|---|---|
| Medacta GMK posterior stabilized prosthesis | Device | Medacta PS |
| Medacta GMK Sphere prosthesis | Device | Medacta Sphere |
Primary outcome
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative
Time frame: Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively
Patient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)
Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.
Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (MCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved physical wellness/function as reported by patients.
PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient
PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain an increased value indicates greater severity/frequency of pain reported by the patient.
PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain an increased value indicates greater severity/frequency of pain reported by the patient
Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life
Time frame: 12 months post-operatively
Patient completed questionnaire used to assess the patients' ability to forget about a joint as a result of successful treatment. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60 where a high score indicates an improved outcome. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score with higher scores indicating improved physical function/reduced impact of symptoms on activity: Final score = 100 - ((sum(item01 to item12) - 12)/48*100)
International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op
Time frame: Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.
The International Knee Documentation Committe (IKDC) Questionnaire is a subjective scale that provides patients with an overall function score based on a summative score for 3 sub categories (knee function, sports activities, pain/symptoms). A score between 0-100 is obtained as the sum of scores for each individual question, with increasing composite scores correlating positively with patient functional status/quality of life.
Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively
Time frame: 12 months post-operatively
Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively
Time frame: 12 months post-operatively
Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)
3 secondary outcomes
Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees)
Time frame: 1 year post-operatively
Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees)
Time frame: 1 year post-operatively
Get-up-and-Go Test
Time frame: Between 6 months and 1 year post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medacta GMK posterior stabilized prosthesis and Medacta GMK Sphere prosthesis in people with Osteoarthritis of Knee, run by Northwestern University at 1 site in United States.
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 4 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 19 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2019). 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?
Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative (time frame: Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively). The study lists 10 primary outcomes in all. 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 19 May 2023.