Clinical trial NCT01548040: Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
Official title: A Randomised Controlled Study To Compare the Effects of a Standard Therapy Protocol With a 12-week Peri-Operative Program of Kneehab XP Compared to a Control Treatment in Patients Undergoing Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Keywords: NMES
Muscle
strength
TKA
Focus to show shorter muscle recovery after Knee operation
Lead sponsor: Theragen Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 111
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Isometric Strength Test
timeFrame: measured at the 6 week post-operative time point
Secondary outcomes:
measure: Percentage of Patients With Positive PASS
timeFrame: measured at the 6 week post-operative time point
Other outcomes:
measure: Physical Therapy Sessions
timeFrame: 1 wk pre-operatively, 3,6,12,52 week post operatively
measure: Questionnaires
timeFrame: 1 wk pre-operatively, 3,6,12,52 week post operatively
measure: Range of Motion
timeFrame: 1 wk pre-operatively, 3,6,12,52 week post operatively
measure: Timed to Get up and go
timeFrame: 1 wk pre-operatively, 3,6,12,52 week post operatively
measure: Stair Climb Test
timeFrame: 1 wk pre-operatively, 3,6,12,52 week post operatively
measure: Visual Analogue Scales (VAS)
timeFrame: 1 wk pre-operatively,3,6,12 and 52 post operatively
Locations:
city: Greenville
country: United States
facility: Hawkins Foundation
state: South Carolina
Study officials:
affiliation: Hawkins Foundation
name: Brian Burnikel
role: PRINCIPAL_INVESTIGATOR
References: