Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty (KneehabTKA)
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|ClinicalTrials.gov Identifier: NCT01096524|
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Disuse Atrophy||Other: Standard Physiotherapy Device: Kneehab||Phase 3|
Knee osteoarthritis is a severe debilitating condition that greatly impacts patient quality of life, function, emotional well-being and everyday pain levels. Total knee arthroplasty (TKA) is performed as a means of alleviating these symptoms in the long term however short term muscle weakness following surgery can elicit its own detrimental effect on performance and activities of daily living. This underlines the importance of mitigating strength loss in the immediate post-operative period.
Recent reviews suggest that Neuromuscular Electrical Stimulation (NMES) of the quadriceps femoris muscle can be beneficial in the rehabilitation period following knee surgery. It appears that early use of NMES can help to recover exercise capacity in the muscle, thus allowing the patient to benefit more from volitional exercise therapy later in the rehabilitation period1. This in turn can lead to accelerated recovery and improved outcomes. A recent and as yet unpublished study of 96 patients following ACL reconstruction has demonstrated a clear benefit to the use of Kneehab. The benefit seemed to accrue in the six-week post-operative period.
A recent pilot study by Walls 2 also suggests that NMES applied in the immediate pre-operative period before TKA leads to increased muscle strength and improved functional abilities. Previously, Mizner (2005) has shown pre operative strength to be a good predictor of functional outcome 1 year after surgery3. This proposed study aims to examine whether NMES applied in the peri-operative timeframe, 6 weeks before and 6 weeks after, can improve outcomes for patients undergoing total knee replacement. The rationale for this approach is that NMES can help prepare the quadriceps muscle for the rehabilitation phase by building exercise capacity before the operation. The immediate deficit, which normally follows knee surgery, would therefore be compensated to some extent and the post-operative NMES treatment would be expected to counteract the activation inhibition that is thought to occur in the early weeks following surgery. Overall, the patient would be in a better position to benefit from conventional rehabilitation exercises aimed at improved co-ordination and functional performance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Control group standard physiotherapy
Standard pathway of care pre-and post-TKA without using NMES.
Other: Standard Physiotherapy
The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES.
Kneehab on the quadriceps of the affected leg, 20 minutes, twice per day, 5 days per week over 12-week intervention (6 weeks pre-op, 6 weeks post op).
NMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA.
Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes.
- Efficacy of Kneehab in promoting early recovery of quadriceps performance following knee arthoplasty. [ Time Frame: 6 weeks Pre-Op and 6, 12 and 52 weeks post op. ]
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).
- Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls. [ Time Frame: 6 Weeks pre-Op and 6, 12 and 52 weeks post-Op ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096524
|Royal Liverpool and Broadgreen University Hospital NHS Trust|
|Liverpool, United Kingdom, L7 8XP|
|Principal Investigator:||Alasdair Santini, M.D.||Royal Liverpool & Broadgreen University Hospital|