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RECRUITING
NCT06264076
NA

Ligament Balancing in Total Knee Arthroplasty

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are: 1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? 2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury? Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital.

Official title: Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DEVICE

A novel instrument for ligament balancing in total knee arthroplasty

Patients will be evaluated perioperatively for ligament balance. When indicated, the novel instrument will guide puncturing of the medial collateral ligament in a systematic and step-wise fashion. Achieved ligament balance will be observed and controlled by computer navigation and a ligament tensor. Performed at Bærum Hospital vestre Viken Hospital Trust.

DEVICE

Novel Instrument for ligament balancing in knee arthroplasty

Patients will be evaluated perioperatively for ligament balance. When indicated, the novel instrument will guide puncturing of the medial collateral ligament in a systematic and step-wise fashion. Achieved ligament balance will be observed and controlled by conventional methods using spatulas.

Locations (2)

Bærum Hospital, Vestre Viken Hospital Trust

Bærums verk, Akershus, Norway

Oslo University Hospital, Ullevaal

Oslo, Oslo County, Norway