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The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492674
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.

An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.

A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.

Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.

Design and Setting: Randomized, controlled and double blind prospective trial

Patients: 120 patients who are candidates to TKA

Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.

The five groups:

  1. Pre- operative BD training and post-operative PT and BD training
  2. Pre- operative sham training and post-operative PT and BD training
  3. Pre- operative sham training and post-operative PT and sham training
  4. No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
  5. No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.

Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.

Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.

Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA


Condition Intervention
Knee Osteoarthritis Device: APOS biomechanical gait system Procedure: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty: A Double Blind Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Detailed Description:

Introduction: Total knee arthroplasty (TKA) is a consensus treatment for end-stage knee osteoarthritis. The peri-operative rehabilitation is an important part of the outcome of such procedure. Previous studies have shown that there is correlation between both pre-operative functional status and the intensiveness of the post-operative rehabilitation to the post operative function of the patient.

An important part of the peri-operative rehabilitation in TKA is the neuromuscular control re-education.

A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of bringing the patient to a functional bio-mechanical alignment during standing and walking, while simultaneously strengthening dynamic stabilizers and training neuromuscular control by means of controlled biomechanical perturbations.

Objectives: The aim of this study is to evaluate the influence of pre and post operative training with the biomechanical device mentioned above on the functional outcome and quality of life of patients undergoing TKA.

Design and Setting: Randomized, controlled and double blind prospective trial

Patients: 120 patients who are candidates to TKA

Interventions: Patients will randomly assigned into five groups (active, sham and control) and will followed for fourteen months (two moths pre-operative and twelve months post-operative). All groups will undergo post-operative physical therapy (PT) according to the standard guidelines. In addition, the active groups will be treated with the device and its four biomechanical elements that had been individually calibrated for each patient. The sham group will be treated with the same device; however, the biomechanical elements will have zero perturbation and will be positioned along the central longitudinal line of the shoe-platform. The control group will be treated only according to the standard post-operative protocol.

The five groups:

  1. Pre- operative BD training and post-operative PT and BD training
  2. Pre- operative sham training and post-operative PT and BD training
  3. Pre- operative sham training and post-operative PT and sham training
  4. No pre-operative training (according to the guidelines in Israel) and post-operative PT and BD training.
  5. No pre-operative training (according to the guidelines in Israel) and post-operative PT and sham training.

Primary Outcome Measures: Spatio-temporal measures (recorded by Gait-Rite™) and the Aggregated Locomotor Function (ALF) assessment.

Secondary Outcome Measures: Pain and function questionnaire measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Quality of life will be evaluated by the SF-36 quality of life questionnaire.

Measurements will be taken at day-1 (two months before the TKA) and at four more stations: 1 Week prior to the TKA, Three months post the TKA, six months post the TKA and twelve months post the TKA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for total knee arthroplasty (d/t osteoarthritis)
  • All operated by the same Surgeons (Prof. Nahum Halperin's group)
  • Identical kind of Prosthesis in use (zimmer Lps-Flex Mobile)

Exclusion Criteria:

  • Prior joint arthroplasty
  • A pathology in additional segment (ankle, hip)
  • Other muscular or neurological disease/condition
  • Mentally or physically impairment that will prevent the patinet from proper use of the biomechanical device.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492674


Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Nahum Halperin, MD Asaf-Harofeh Medical Center
Study Chair: Zeevi Dvir, PhD Tel Aviv University
Principal Investigator: Noga Gal, Msc Tel Aviv University
  More Information

ClinicalTrials.gov Identifier: NCT00492674     History of Changes
Other Study ID Numbers: 35/07
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
Last Verified: April 2007

Keywords provided by Assaf-Harofeh Medical Center:
TKA
Arthroplasty
Knee
Osteoarthritis
Rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases