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Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense

NCT03286868 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-17

No results posted yet for this study

Summary

Total Knee Replacement (TKR) is an operation to help with the pain and decreased function that happens with end stage arthritis of the knee. This operation has been shown to be very successful at relieving pain and improving patient mobility; however, some studies have shown that up to 20% of TKR recipients are not happy with their knee replacement.

All of the reasons why some patients are not pleased with the outcome of surgery are not known, but one of the possible causes is the way the implants are placed, or aligned, during surgery. Most TKRs are aligned in a fashion that the bones in the leg are completely straight after surgery. This is known as mechanically aligning a TKR. A different alignment method known as kinematic alignment respects the natural bow legged or knock kneed alignment of the patient. It is hoped that kinematically aligning a knee replacement will improve how the knee feels to the patient and therefore improve their satisfaction.

Another potential factor affecting the outcomes of TKR is obtaining optimal soft tissue balance. The challenge with balancing a TKR is that traditional operative techniques rely on subjective feel of the knee stability during surgery. The balance or tension in the knee can however be objectively measured using specialized intraoperative pressure sensing devices.

The purpose of this study is to assess the impact of kinematically aligned TKR on the pressures measured by Verasense during total knee replacements. The study will also determine if differences in the pressure measured during TKR surgery impact patient outcomes after surgery.

Conditions

  • Osteo Arthritis Knee

Interventions

PROCEDURE

Total Knee Arthroplasty

Total Knee Arthroplasty

DEVICE

Total Knee Arthroplasty with Verasense sensor

Total Knee Arthroplasty with Verasense sensor

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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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 NCT03286868 on ClinicalTrials.gov