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Ligament Balancing in Total Knee Arthroplasty

NCT06264076 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Lars HW Engseth, MD · Oslo University Hospital, Ullevaal, Oslo, Norway

  • Jarle Vik, MD · Baerum Hospital, Vestre Viken Hospital Trust, Baerum, Norway

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264076 on ClinicalTrials.gov