Actively Recruiting
A Post-market Observational ORIGIN4 CR Clinical Study Evaluating Safety and Performance in Total Knee Replacement
Led by Symbios Orthopedie SA · Updated on 2024-10-08
199
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the ORIGIN4 CR (cruciate retaining) devices used in total knee replacement surgery. This observational study aims to measure the safety by tracking the proportion of patients needing revision surgery one year after the procedure and to assess performance using the Knee Society Score (KSS) both for the knee and function at one year. The hypothesis is that patients will notice a significant natural feel improvement in the prosthesis within the first year, with slight further gains at two years, along with better overall satisfaction. The study will include 199 patients who will receive treatment with the ORIGIN4 CR devices and associated instruments. Patients will be enrolled over an 18-month period and followed for 24 months. This single-arm study does not include a comparison group and will monitor patients up to two years after their surgery to assess outcomes. Participants will be asked to attend follow-up visits at one and two years after their surgery. During these visits, researchers will evaluate safety through revision rates and assess performance using the Knee Society Score and Function Score, patient satisfaction surveys, and the Forgotten Joint Score questionnaire. The study focuses on understanding quality of life and prosthesis function after total knee replacement with the ORIGIN4 CR device.
CONDITIONS
Brief Title
A Post-market Observational ORIGIN® CR Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female over 18 years of age
- Willing to give informed consent
- Clinically indicated for total knee replacement
- Females not pregnant and not planning pregnancy within 12 months; pregnancy test required if of childbearing age
- Geographically stable and willing to return for follow-up visits at 1 and 2 years
You will not qualify if you...
- Acute or chronic local or systemic infection
- Muscular, ligamental, neurological, psychological, or vascular deficits
- Bone destruction or poor bone quality affecting implant stability
- Conditions likely to affect implant integration or function
- Allergy or hypersensitivity to implant materials
- Renal or hepatic impairment for CoCrMo devices
- Hip Knee Ankle angle less than 1656 or greater than 1956
- Severe collateral ligament deficiency requiring constrained prosthesis
- Posterior cruciate ligament deficiency
- Major anatomical deformities
- Severe flexion contracture or severe recurvatum
- Revision of previous knee prosthesis
- Presence of non-extractible materials conflicting with implant
- Excessive femoral or tibial bone loss beyond component thickness
- Bone degradation requiring anchoring stem for femoral component
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 18 months
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility assessment
Duration - Day of surgery
Participants undergo total knee replacement with the ORIGIN® CR device as part of routine clinical care.
1 visit (in-person) on the day of surgery
Duration - 24 months after surgery
Participants are followed to evaluate the safety and performance of the device and their recovery progress.
Follow-up visits at 1 year and 2 years post-procedure
Trial Site Locations
Total: 2 locations
1
GZA Ziekenhuizen - campus Sint-Augustinus
Antwerp, Belgium, 2610
Actively Recruiting
2
AZ Voorkempen
Malle, Belgium, 2390
Actively Recruiting
Research Team
B
Bojana Gannevat
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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