Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty

NCT01096524 | Completed Phase 3

• 2 other identifiers: BMR-09-10072008-008483-27
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Disuse Atrophy

Keywords

Kneehab; NMES; Total Knee Arthroplasty; Total Knee Replacement; TKA; Disuse atrophy; muscle hypertrophy; TKR; Atrophy Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Determine the effect of Kneehab in promoting quality of life measures and health economic outcomes, compared to controls.

  6 Weeks pre-Op and 6, 12 and 52 weeks post-Op

Study Arms (2)

Control group standard physiotherapy

OTHER

Standard pathway of care pre-and post-TKA without using NMES.

Other: Standard Physiotherapy

Kneehab

EXPERIMENTAL

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

Interventions

Standard Physiotherapy OTHER

The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES.

Control group standard physiotherapy

Kneehab DEVICE

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.

Also known as: Neuromuscular Electrical Stimulation, NMES

Kneehab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Royal Liverpool and Broadgreen University Hospital NHS Trust

Liverpool, Liverpool, L7 8XP, United Kingdom

Location

Related Publications (4)

• Paillard T. Combined application of neuromuscular electrical stimulation and voluntary muscular contractions. Sports Med. 2008;38(2):161-77. doi: 10.2165/00007256-200838020-00005.

  PMID: 18201117 BACKGROUND

• 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.

  PMID: 16078331 BACKGROUND

• 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. doi: 10.1016/S0736-0266(03)00052-4.

  PMID: 12919862 BACKGROUND

• 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. doi: 10.1186/1471-2474-7-100.

  PMID: 17156487 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Muscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Alasdair Santini, M.D.

  Royal Liverpool & Broadgreen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2014

Record last verified: 2013-08

Locations

GB (1)