Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

NCT01548040 | Completed Results

• 1 other identifier: Pro00012744
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.

Conditions

Total Knee Replacement

Keywords

NMES; Muscle; strength; TKA; Focus to show shorter muscle recovery after Knee operation

Outcome Measures

Primary Outcomes (1)

• Isometric Strength Test

  To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.

  measured at the 6 week post-operative time point

Secondary Outcomes (1)

• Percentage of Patients With Positive PASS

  measured at the 6 week post-operative time point

Other Outcomes (6)

• Physical Therapy Sessions

  1 wk pre-operatively, 3,6,12,52 week post operatively

• Questionnaires

  1 wk pre-operatively, 3,6,12,52 week post operatively

• Range of Motion

  1 wk pre-operatively, 3,6,12,52 week post operatively

Study Arms (2)

quadriceps NMES using Kneehab XP

EXPERIMENTAL

All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation (NMES) using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

Device: Kneehab XP

quadriceps TENS

SHAM COMPARATOR

The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps Transcutaneous Electrical Nerve Stimulation (TENS) at a minimal sensory input using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation

Device: Quadriceps TENS

Interventions

Kneehab XP DEVICE

NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively

quadriceps NMES using Kneehab XP

Quadriceps TENS DEVICE

on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.

quadriceps TENS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are scheduled for Total Knee Replacement surgery with the Smith and Nephew Visionaire prosthesis and the anterior surgical approach.
• Individuals who are at least 40 years of age.
• Individuals with a body mass index (BMI) \<40 kg/ m2
• Individuals who are walking independently with or without assistive devices.
• Individuals with a Short Performance Battery Score greater than 7.
• 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 the additional pre-operative assessment.

You may not qualify if:

• Individuals with a history of foot and/or ankle pathology.
• Individuals with a history of tibial or femoral fractures.
• Individuals with a history of any 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.
• Individuals who are pregnant.
• Individuals diagnosed with 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 (Rheumatoid arthritis, gout or psoriatic arthritis).
• Individuals with muscle diseases (i.e. muscular dystrophy)
• Individuals with visible skin injury or disease on their legs.
• Individuals who have been committed to an institution by virtue of an order issued either by the courts or by an authority.

Sponsors & Collaborators

• Theragen Inc.: lead

Study Sites (1)

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

Results Point of Contact

• Title: Richard Pearce
• Organization: Theragen Inc.

richard.pearce@theragen.com

901 634 0544

Study Officials

• Brian Burnikel

  Hawkins Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 8, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 11, 2018
• Results First Posted: March 19, 2018

Record last verified: 2018-03

Locations

US (1)