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

NCT03286868 | Recruiting FDA Device

• 1 other identifier: TKA VERA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• gait assessment

  kinematic gait assessment using KneeKG

  2 years

Secondary Outcomes (2)

• EQ-5D patient reported outcome measure

  2 years

• Ligament releases

  Intra-operative

Study Arms (2)

Standard of Care TKA

PLACEBO COMPARATOR

Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery

Procedure: Total Knee Arthroplasty

TKA with Verasense sensor

EXPERIMENTAL

Total Knee Arthroplasty (TKA) with Verasense sensor for Intraoperative Balancing: Surgeon will attempt to optimize the intraoperative pressures using the data from the Verasense sensor

Device: Total Knee Arthroplasty with Verasense sensor

Interventions

Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty

Standard of Care TKA

Total Knee Arthroplasty with Verasense sensor DEVICE

Total Knee Arthroplasty with Verasense sensor

TKA with Verasense sensor

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic arthritis of the knee indicating primary total knee arthroplasty
• Between the ages of 21 and 80 inclusive
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent
• Varus alignment

You may not qualify if:

• Patients less than 21 years of age, or 81 years of age and older
• Unable to provide consent
• BMI \>45
• Pregnancy
• Patients with inflammatory arthritis, posttraumatic osteoarthritis, post high tibial osteotomy, or arthritis due to sepsis will be excluded.
• Active or prior infection
• Medical condition precluding major surgery
• Severe osteoporosis or osteopenia
• Neuromuscular impairment
• Significant co-morbidity affecting ability to ambulate
• Valgus alignment

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Research Manager

CONTACT

902-473-3883; elise.laende@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 19, 2017
• Study Start: July 23, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

CA (1)