Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Medial Gonarthrosis. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
Detailed description
In knee surgery, two dominant designs exist for the medial unicompartmental knee prosthesis (UKP): the fixed bearing (FB) and mobile bearing (MB) designs. The FB design is technically simpler to implant but has shown higher rates of early polyethylene wear in some studies. MB implants theoretically offer advantages in joint kinematics and load distribution but carry a risk of insert dislocation and periprosthetic fractures. An additional advantage of MB implants is the possibility of cementless implantation, potentially avoiding cement-related complications and reducing operative time.
Primary outcome measures
- OKS [Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
Secondary outcome measures (12)
- AMI [Time frame: Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.]
- Surgery time [Time frame: Peroperatively]
- Complications [Time frame: Within 2 years postoperatively]
- Revision or reoperation [Time frame: Within 2 years postoperatively]
- c-FCA [Time frame: 6 weeks and 4 months postoperatively]
- EQ-5D-5L [Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
- NRS [Time frame: Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]]
- KOOS-PS [Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
- c-TCA [Time frame: 6 weeks and 4 months postoperatively]
- s-FCA [Time frame: 6 weeks and 4 months postoperatively]
- s-FCA [Time frame: 6 weeks and 4 months postoperatively]
- RLL [Time frame: 6 weeks and 4 months postoperatively]
Eligibility criteria
Inclusion criteria
- Age between 50 and 80 years
- Indication for medial UKP
- Intact anterior cruciate ligament
- Good bone quality based on imaging
- ASA score ≤ 3
Exclusion criteria
- Inflammatory joint diseases
- Collateral ligament instability
- Simultaneous bilateral procedure
- BMI > 35
- History of fracture or osteotomy in the knee joint
- Neuromuscular diseases
- Oncological indications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Orthopedic department — Ieper
Identifiers
NCT: NCT07677722 · FiMO JYZ2025-10