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

Knee Osteoarthritis Clinical Trial

Official title:

The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty: A Double Blind Randomized Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00492674
• Other study ID #: 35/07
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2007
• Last updated: June 26, 2007

Study information

• Verified date: April 2007
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• APOS biomechanical gait system

Procedure:
• Physical Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center