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

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ClinicalTrials.gov Identifier: NCT03286868
Recruitment Status : Unknown
Verified February 2018 by Glen Richardson, Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Glen Richardson, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Procedure: Total Knee Arthroplasty Device: Total Knee Arthroplasty with Verasense sensor Not Applicable

Detailed Description:

The primary objective of this research study is to evaluate the use of the Verasense pressure sensor to optimize intraoperative implant pressures/balance during computer assisted TKR utilizing pre- and postoperative kinematic alignment techniques.

This is a randomized controlled trial where 60 patients will undergo a kinematically aligned TKR using VERASENSE pressure sensors. Patients will be randomly assigned to either TKR balancing using VERASENSE data (TKR-V), or TKR using standard surgeon decision making in balancing (TKR only). In the TKR only group, the surgeon will perform the surgery while blinded to the data output of the VERASENSE sensor and will use standard surgeon decision making to balance the TKR. In the second group, TKR-V, the surgeon will not be blinded to the data output of the VERASENSE sensor and will use the data to influence how they balance the TKR.

The primary outcome measure will be postoperative kinematic gait assessment to evaluate the effect of optimizing patient soft tissue balance using Verasense pressure sensor. Secondary outcomes will include the number of intraoperative soft tissue releases, and results of health outcome questionnaires.

Research Questions:

  1. What are the differences and similarities between the subjective surgeon-balanced group (standard of care) compared to the objective Verasense-balanced group?
  2. Is there a difference in the number of "poorly balanced" knees between the surgeon-balanced kinematically aligned groups compared to the Verasense-balanced kinematically aligned group?
  3. Is there an effect of preoperative alignment on ligament balancing using Verasense pressure sensor?
  4. Is there a difference in the number of ligament releases required to optimize soft tissue balance between the Verasense pressure sensor aided total knee replacements and those balanced by the surgeon alone?
  5. What is the effect of optimizing patient soft tissue balance with Verasenes pressure sensor on gait parameters measured with Knee KG?

ANOVA will be used to examine pre and post-operative differences in specific features of knee kinematics between groups. Primary and secondary outcomes will be evaluated using listings and summary statistics. Improvement in pain and function will be analyzed using t-test or Wilcoxon Rank tests.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Balancing Kinematically Aligned Total Knee Replacements During Total Primary Knee Arthroplasty Using Verasense
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: Standard of Care TKA
Standard of Care Total Knee Arthroplasty (TKA): No data from the Verasense sensor will be used to influence the surgery
Procedure: Total Knee Arthroplasty
Total Knee Arthroplasty

Experimental: TKA with Verasense sensor
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
Total Knee Arthroplasty with Verasense sensor




Primary Outcome Measures :
  1. gait assessment [ Time Frame: 2 years ]
    kinematic gait assessment using KneeKG


Secondary Outcome Measures :
  1. EQ-5D patient reported outcome measure [ Time Frame: 2 years ]
    Health status measure

  2. Ligament releases [ Time Frame: Intra-operative ]
    Number of ligament releases required during knee replacement



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
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Responsible Party: Glen Richardson, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03286868    
Other Study ID Numbers: TKA VERA
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases