Actively Recruiting
A Post-market Observational ORIGIN® CR Clinical Study
Led by Symbios Orthopedie SA · Updated on 2024-10-08
199
Participants Needed
2
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Post-market Observational ORIGIN® CR Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Willing to provide informed consent
- Clinically indicated for total knee replacement surgery
- Females must not be pregnant or planning pregnancy within 12 months; pregnancy test required for women of childbearing age
- Geographically stable and willing to return to the implanting site for follow-up visits at 1 year and 2 years
You will not qualify if you...
- Acute or chronic infection, local or systemic
- Muscular, ligament, 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 device materials
- Renal or hepatic impairment for devices made of CoCrMo
- Hip Knee Ankle angle less than 1656 or greater than 1956
- Severe collateral ligament deficiency
- Posterior cruciate ligament deficiency
- Major anatomical deformities
- Severe flexion contracture or recurvatum
- Revision of previous knee prosthesis
- Non-extractible materials conflicting with prosthesis components
- Excessive femoral or tibial bone loss beyond component thickness
- Bone degradation requiring anchoring stem for femoral component
AI-Screening
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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
CONTACT
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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