Improving ligament balance during total knee replacement
Official title: Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique
Run by Oslo University Hospital · NCT06264076 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Bærums verk, Akershus and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT06264076 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Oslo University Hospital, Ullevaal
Oslo, Oslo, Norway Recruiting -
Bærum Hospital, Vestre Viken Hospital Trust
Bærums verk, Akershus, Norway Completed
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effects of virtual reality on walking in adults with knee osteoarthritis
This study tests how immersive virtual reality environments—designed to feel safe or to provoke fear—affect walking and worry about movement in adults 50 and older with knee osteoarthritis and in healthy peers.
-
Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese
This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).
-
Autologous adipose-derived stem cell injections for knee osteoarthritis
We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.
-
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
This study tests whether higher burden of preoperative multimorbidity affects functional recovery after knee replacement in adults with knee osteoarthritis.
-
Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status
Researchers will test whether a 30-minute treadmill walk changes cartilage biomarkers in postmenopausal women with knee osteoarthritis, comparing those on denosumab, bisphosphonates, and those not on antiresorptives.
-
Lysyl Enzymes in Knee Osteoarthritis
This study tests whether blood levels of lysyl hydroxylase and lysyl oxidase differ between people with knee osteoarthritis and healthy individuals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.