Orthopedic department
Ieper, Oost-Vlaanderen, 8900, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT07677722
Prospective Comparative Study of Clinical Outcomes and Complications in Medial Knee Prostheses: Fixed Bearing Versus Mobile Bearing Design
This prospective study aims to systematically compare the clinical and radiological outcomes and complications of mobile versus fixed unicompartimental knee prostheses.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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OKS
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
Oxford Knee Score
Secondary outcomes
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AMI
Time frame: Evaluate AMI (Arthrogenic Muscle Inhibition) preoperative, at 6 weeks and 4 months postoperative.
Arthrogenic Muscle Inhibition - DOI: 10.1002/ksa.12804 for grading
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Surgery time
Time frame: Peroperatively
Operative time
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Complications
Time frame: Within 2 years postoperatively
Postoperative complications
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Revision or reoperation
Time frame: Within 2 years postoperatively
Revision or reoperation
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c-FCA
Time frame: 6 weeks and 4 months postoperatively
Coronal Femoral Component Alignment - Varus/valgus alignment for the femoral component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° degrees is considered neutral.
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EQ-5D-5L
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
The 5-level EQ-5D version.
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NRS
Time frame: Preoperatively, one week, 6 weeks, 4 months, 12 months, and 24 months postoperatively.]
Numeric Rating Scale
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KOOS-PS
Time frame: Preoperatively, 6 weeks, 4 months, 12 months, and 24 months postoperatively.
Knee Injury and Osteoarthritis Outcome Score-Physical function Short form
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c-TCA
Time frame: 6 weeks and 4 months postoperatively
Coronal Tibial Component Alignment - Varus/valgus alignment for the tibial component is measured on the AP radiograph in relation to the anatomical axis of the tibia. 0° is considered neutral.
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s-FCA
Time frame: 6 weeks and 4 months postoperatively
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior tibial cortex. A posteroinferior slope of 7° is considered neutral.
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s-FCA
Time frame: 6 weeks and 4 months postoperatively
Sagittal Femoral Component Alignment - Flexion/extension is measured on a lateral radiograph, relative to the posterior femoral cortex. 0° is considered neutral.
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RLL
Time frame: 6 weeks and 4 months postoperatively
Radiolucencies - Radiolucencies after UKR are divided into two types:
physiological and pathological. The former are < 2 mm thick, well defined, and accompanied by a parallel radiodense line, whereas the latter are > 2 mm thick, ill defined, and lacking accompanying radiodense lines. The pattern observed should be recorded as well as their location, which is divided into six zones on the AP view of the tibial component and six zones on the lateral view of the femoral component. Evaluation based on the zones of the Knee Society.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Jan Yperman Hospital
Other
Registry information
Acronym: FiMo_UKP
Important dates
- Study start
- 2025
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Jul 1, 2026
- Registry last updated
- Jul 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.