Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

NCT ID: NCT01548040

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.

Conditions

Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

quadriceps NMES using Kneehab XP

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

Group Type: EXPERIMENTAL

Kneehab XP

Intervention Type: 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 TENS

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

Group Type: SHAM_COMPARATOR

Quadriceps TENS

Intervention Type: 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.

Interventions

Kneehab XP

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

Intervention Type: DEVICE

Quadriceps TENS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theragen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Burnikel

Role: PRINCIPAL_INVESTIGATOR

Hawkins Foundation

Locations

Hawkins Foundation

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Pro00012744

Identifier Type: -

Identifier Source: org_study_id