Comparing two types of knee replacement surgery for osteoarthritis
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study
This study tests which type of knee replacement surgery works better for people over 50 with osteoarthritis, comparing a new design to a standard one to see which helps them move and feel happier after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 99 Years |
| Sex | All |
| Sponsor | Elda University Hospital Academic / other |
| Locations | 1 site (Elda, Alicante) |
| Trial ID | NCT04769544 on ClinicalTrials.gov |
What this trial studies
This study evaluates the functional outcomes and longevity of two different total knee arthroplasty (TKA) designs: a medial pivot insert and a conventional symmetrical insert. Eligible patients aged 50 and older with primary knee osteoarthritis will be randomly assigned to one of the two groups. The study will assess preoperative and postoperative outcomes at regular intervals, ensuring that evaluations are conducted by independent orthopedic surgeons not involved in the surgeries. The goal is to determine which design provides better kinematic function and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with primary osteoarthritis of the knee who can provide informed consent.
Not a fit: Patients with inflammatory arthritis, severe knee misalignment, or prior knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have explored various TKA designs, but this specific comparison of medial pivot versus symmetrical inserts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary osteoarthritis of the knee * 50 years and older * Participants must be able to give informed consent Exclusion Criteria: * Inflammatory arthritis * Traumatic etiology * Neurologic disease * Neoplastic disease * Morbid obesity * Severe collateral ligament instability (\> 10° varus/valgus) * Severe knee misalignment (greater than 10° of varus or valgus) * Flexion contracture greater than 15º * Prior surgery on the affected knee (except meniscus) * Knee arthroplasty in the contralateral knee
Where this trial is running
Elda, Alicante
- Elda University Hospital — Elda, Alicante, Spain (Recruiting)
Study contacts
- Principal investigator: Alejandro Lizaur-Utrilla, MD, PhD — Elda University Hospital
- Study coordinator: Alejandro Lizaur-Utrilla, MD, PhD
- Email: lizaur1@telefonica.net
- Phone: +34 966989019
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.