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