Improving ligament balance during total knee replacement
Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique
This tests a new surgical instrument to more predictably lengthen the medial collateral ligament (MCL) during total knee replacement for adults with varus knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Bærums verk, Akershus and 1 other locations) |
| Trial ID | NCT06264076 on ClinicalTrials.gov |
What this trial studies
This is a pilot interventional study of a novel device designed to standardize ligament lengthening of the MCL during total knee arthroplasty. Patients consent before surgery but are enrolled only if the surgeon finds that intraoperative ligament balancing is needed. The device is used during the operation to perform a controlled MCL lengthening and measurements are collected to compare repeatability and safety versus conventional techniques. Participants receive routine postoperative follow-up per the hospital's standard TKA protocol.
Who should consider this trial
Good fit: Adults over 40 undergoing primary total knee replacement for osteoarthritis or related indications with a varus deformity and who are otherwise in reasonable health are the intended candidates.
Not a fit: Patients undergoing revision or reoperation, those with considerable prior knee injury, isolated patellofemoral disease, or who do not require intraoperative ligament balancing are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the instrument could make medial ligament releases more consistent and reproducible, which may improve alignment and functional outcomes after knee replacement.
How similar studies have performed: Existing techniques such as Bellemans' pie-crusting and Whiteside's sequential releases are commonly used but show variable lengthening results, and using a dedicated instrument for more objective, repeatable MCL lengthening is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women over 40 years of age that require total knee arthroplasty * Idiopathic osteoarthrosis, osteonecrosis or avascular osteonecrosis * Otherwise fairly healthy/ no significant health issues Exclusion Criteria: * Age under 40 years of age * Pregnant * Revisions or reoperations * Considerable earlier injury to the knee * Isolated patellofemoral osteoarthrosis
Where this trial is running
Bærums verk, Akershus and 1 other locations
- Bærum Hospital, Vestre Viken Hospital Trust — Bærums verk, Akershus, Norway (Completed)
- Oslo University Hospital, Ullevaal — Oslo, Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Lars HW Engseth, MD — Oslo University Hospital, Ullevaal, Oslo, Norway
- Study coordinator: Lars HW Engseth, MD
- Email: laengs@ous-hf.no
- Phone: 004741254136
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.