Knee Osteoarthritis Clinical Trial
— KneehabTKAOfficial title:
Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals who are scheduled for elective Total Knee Replacement surgery - Individuals who are at least 18 years of age - Individuals with a body mass index (BMI) <40 - Individuals who are walking independently with or without assistive devices - Must be able and willing to complete all study assessments and to be followed for the full course of the study. - Must be able to read, write and follow instructions in English. - Must be able and willing to provide informed consent. - Must be willing and able to attend for pre-op assessment Exclusion Criteria: - Individuals who have failed the pre-operative assessment - Individuals with a history of foot and/or ankle pathology - Individuals with a history of tibial or femoral fractures - Individuals with a history of underlying neurological conditions - Individuals with physical conditions which would make them unable to perform study procedures - Individuals with a total hip replacement - Individuals undergoing revision TKA of the same operated leg - Pregnant women or inadequate precautions to prevent pregnancy - Diagnosis of a medical condition that would contraindicate treatment with the product,e.g skin lesions at electrode site. - Individuals with an active implanted medical device (i.e. pacemaker, pump) - Individuals with a history of stroke - Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.) - Individuals with a diagnosis of inflammatory arthritis (including Rheumatoid Arthritis, gout or psoriatic arthritis) - Individuals with muscle disease (i.e. muscular dystrophy) - Visible skin injury or disease on their legs - Principal investigator for this study, or member of study staff |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Liverpool and Broadgreen University Hospital NHS Trust | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Bio-Medical Research, Ltd. | Royal Liverpool and Broadgreen University Hospitals NHS Trust |
United Kingdom,
Kennedy DM, Stratford PW, Hanna SE, Wessel J, Gollish JD. Modeling early recovery of physical function following hip and knee arthroplasty. BMC Musculoskelet Disord. 2006 Dec 11;7:100. — View Citation
Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9. — View Citation
Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. Review. — View Citation
Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty. | Isometric muscle strength of the knee extensors will be measured by dynamometer with the knee flexed to 60°. Functional ability will be measured using the Timed Get Up and Go (TUG) and Stair Climb Test (SCT). |
6 weeks Pre-Op and 6, 12 and 52 weeks post op. | No |
Secondary | Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls. | Administration of the Western Ontario McMaster University Osteoarthritis Index (WOMAC) and The Medical Outcomes Survey (SF-12). Health economic data will include patient length of stay post surgery; number of outpatient physiotherapy visits in the following year, and change in analgesic medication use during the 6 weeks pre- and 12 weeks post surgery. | 6 Weeks pre-Op and 6, 12 and 52 weeks post-Op | No |
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