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

NCT00492674 | Unknown

• 1 other identifier: 35/07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Osteoarthritis

Keywords

TKA; Arthroplasty; Knee; Osteoarthritis; Rehabilitation

Interventions

APOS biomechanical gait system DEVICE

Physical Therapy PROCEDURE

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Nahum Halperin, MD

  Asaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

• Zeevi Dvir, PhD

  Tel Aviv University

  STUDY CHAIR

• Noga Gal, Msc

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Last Updated: June 27, 2007

Record last verified: 2007-04