- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05607966
A Post-market Observational ORIGIN® CR Clinical Study
The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure.
The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments.
Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female over 18 years of age
- Each patient who is willing to give informed consent.
- Clinically indicated for a total knee replacement
- Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
- Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.
Exclusion Criteria:
- Life expectancy ≤ 1 year
- Acute or chronic, local or systemic infection
- Mental illness
- Muscular, ligamental, neurological, psychological or vascular deficits
- Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert)
- Any concomitant condition likely to affect implant integration or function
- Allergy or hypersensitivity to any of the materials used
- For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
- Hip Knee Ankle (HKA) angle < 165° or > 195°
- Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
- Posterior cruciate ligament deficiency
- Major anatomical deformities
- Severe flexion contracture or severe recurvatum
- Revision of a partial or total knee prosthesis
- Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material…) which can create a conflict with any component of the prosthesis
- Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness
- Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate safety by the proportion of required revisions
Time Frame: 1 year post-procedure
|
Proportion of patients requiring a revision after 1-year post-procedure.
The revision rate is consistent with the state of the art - Orthopaedic Data Evaluation Panel (ODEP) benchmark system (revision rate not higher than 2.5% to 3.5% at 1 year, 4% to 6% at 5 years and 5% to 7% at 10 years).
|
1 year post-procedure
|
Evaluate performance
Time Frame: 1 year post-procedure
|
Evaluate performance by means of following questionnaires: Knee Society Score (KSS) and a Knee Society Function score, a partient-reported outcome measure. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The maximum points which can be reached are 100 points.
|
1 year post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate safety by the proportion of required revisions
Time Frame: 2 years post procedure
|
Proportion of patients requiring a revision after 2 years post-procedure.
|
2 years post procedure
|
Performance on patient satisfaction
Time Frame: 1- and 2-years post-procedure
|
Patient satisfaction questionnaires at 1 year and 2 years follow-up visits.
|
1- and 2-years post-procedure
|
Quality of Life post-procedure measured by the Knee Society score and Knee Society function questionnaire
Time Frame: 1- and 2-years post-procedure
|
Quality of Life measured by means of the Knee Society score and Knee Society function score questionnaires at 1- and 2-years follow-up visit.
|
1- and 2-years post-procedure
|
Quality of Life post-procedure measured by the Forgotten Joint Score questionnaire
Time Frame: 1- and 2- years post-procedure
|
Quality of Life measured by means of the Forgotten Joint Score questionnaire at 1- and 2-years follow-up visit. 12 questions refer to how aware the patients are of their artificial hip/knee joint in everyday life Scoring: For scoring the FJS-12, all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items. This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100, to change the direction of the final score in a way that high scores indicate a high degree of "forgetting" the artificial joint, that is, a low degree of awareness. If more than 4 responses are missing, the total score should not be used. |
1- and 2- years post-procedure
|
Quality of Life post-procedure measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score questionnaire
Time Frame: 1- and 2- years post-procedure
|
Quality of Life measured by means of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire at 1- and 2-years follow-up visit. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually, a sum of the scores for all three subscales gives a total WOMAC score, which is 96 points. |
1- and 2- years post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CLIN-G-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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