Clinical trial NCT00492674: The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty
Official title: The Effect of Perioperative Neuromuscular Training on the Outcome of Total Knee Arthroplasty: A Double Blind Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: TKA
Arthroplasty
Knee
Osteoarthritis
Rehabilitation
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-27
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asaf-Harofeh Medical Center
name: Nahum Halperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Zeevi Dvir, PhD
role: STUDY_CHAIR
affiliation: Tel Aviv University
name: Noga Gal, Msc
role: PRINCIPAL_INVESTIGATOR
References: