Evaluating the ORIGIN® CR knee prosthesis after total knee replacement
A Post-market Observational ORIGIN® CR Clinical Study
This study is testing how well the ORIGIN® CR knee prosthesis works and if it helps people feel better and move easier after total knee replacement surgery over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 199 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Symbios Orthopedie SA Industry-sponsored |
| Locations | 2 sites (Antwerp and 1 other locations) |
| Trial ID | NCT05607966 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of the ORIGIN® CR devices used in total knee replacement surgeries. It will involve 199 patients who will be monitored for one year post-surgery to evaluate the revision rate and improvements in knee function using the Knee Society Score. The study hypothesizes that patients will experience significant improvements in the feel and function of the prosthesis within the first year, with continued benefits observed at the two-year mark. Participants will be followed for a total of 24 months to gather comprehensive data on outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are clinically indicated for a total knee replacement and can provide informed consent.
Not a fit: Patients with acute or chronic infections, significant bone quality issues, or other conditions affecting implant integration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and outcomes following total knee replacement surgeries.
How similar studies have performed: Similar observational studies have shown promise in evaluating knee prosthesis performance, but this specific approach with the ORIGIN® CR device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Acute or chronic, local or systemic infection * 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) * Bone degradation requiring an anchoring stem for femoral component
Where this trial is running
Antwerp and 1 other locations
- GZA Ziekenhuizen - campus Sint-Augustinus — Antwerp, Belgium (Recruiting)
- AZ Voorkempen — Malle, Belgium (Recruiting)
Study contacts
- Study coordinator: Bojana Gannevat
- Email: bojana.gannevat@symbios.ch
- Phone: +41 4242626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.