Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

Theragen

Status: Completed

Conditions: Total Knee Replacement

Treatments: Device: Quadriceps TENS; Device: Kneehab XP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548040

Pro00012744

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

111 participants in 2 patient groups

quadriceps NMES using Kneehab XP

Experimental group

Description:

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

Treatment:

Device: Kneehab XP

quadriceps TENS

Sham Comparator group

Description:

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

Treatment:

Device: Quadriceps TENS