Comparing unicondylar and total knee replacements for knee osteoarthritis
Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
NA · Karolinska Institutet · NCT02563756
This study is testing whether a less invasive knee surgery called unicompartmental knee replacement can help people with knee osteoarthritis recover better and feel more satisfied compared to total knee replacement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT02563756 on ClinicalTrials.gov |
What this trial studies
This study compares the outcomes of patients with medial gonarthritis who undergo either unicompartmental knee replacement (UKR) or total knee replacement (TKR). Patients are randomized to receive one of the two surgical interventions, and their thigh muscle mass, knee function, and overall quality of life are assessed post-surgery. Primary outcomes include measurements of thigh muscle cross-sectional area and radiological attenuation via CT, while secondary outcomes involve various functional tests and patient-reported outcomes. The goal is to determine if less invasive surgery leads to better recovery and satisfaction.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 or older with unilateral medial osteoarthritis of the knee classified as Kellgren 3b-4.
Not a fit: Patients with significant knee deformities, previous knee surgeries, or other conditions affecting mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which surgical approach provides better functional outcomes and quality of life for patients with knee osteoarthritis.
How similar studies have performed: Previous studies have shown promising results in comparing surgical approaches for knee osteoarthritis, suggesting potential benefits from less invasive techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * medial gonarthritis, (Kellgren 3b-4) * correctible varus deformity less than 10 degrees * intact ACL * proficient in written and spoken swedish Exclusion Criteria: * Valgus gonarthritis * flexion deformity of 10 degrees * knee flexion of less than 100 degrees * previous high tibial osteotomy * neuromuscular disorders of lower extremities * symptomatic osteoarthritis of the contralateral knee or any hip.
Where this trial is running
Stockholm
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Margareta Hedström, MD,PhD — CLINTEC, Karolinska Institutet
- Study coordinator: Margareta Hedström, MD, PhD
- Email: margareta.hedstrom@ki.se
- Phone: +4670735959
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.
Conditions: Knee Osteoarthritis, Medial gonarthritis, knee osteoarthritis,, Muscle function, muscle mass, muscle atrophy, Total knee arthroplasty, Unicondylar knee arthroplasty, Total knee replacement, Unicondylar knee replacement, Health-related quality of life