Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty (KneehabTKA)

This study has been completed.
Sponsor:
Collaborator:
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Information provided by (Responsible Party):
Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier:
NCT01096524
First received: March 24, 2010
Last updated: July 18, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Disuse Atrophy
Other: Standard Physiotherapy
Device: Kneehab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).

Resource links provided by NLM:


Further study details as provided by Bio-Medical Research, Ltd.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Standard physiotherapy
Experimental: Kneehab
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).
Device: Kneehab

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.

Other Names:
  • Kneehab
  • Neuromuscular Electrical Stimulation
  • NMES

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096524

Locations
United Kingdom
Royal Liverpool and Broadgreen University Hospital NHS Trust
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Bio-Medical Research, Ltd.
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Investigators
Principal Investigator: Alasdair Santini, M.D. Royal Liverpool & Broadgreen University Hospital
  More Information

Publications:
Responsible Party: Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier: NCT01096524     History of Changes
Other Study ID Numbers: BMR-09-1007, 2008-008483-27
Study First Received: March 24, 2010
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bio-Medical Research, Ltd.:
Kneehab
NMES
Total Knee Arthroplasty
Total Knee Replacement
TKA
Disuse atrophy
muscle hypertrophy
TKR
Atrophy Prevention
Disuse Atrophy

Additional relevant MeSH terms:
Osteoarthritis
Muscular Disorders, Atrophic
Atrophy
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014