N/A
N=111
Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement
Total Knee Replacement
Bottom Line
View on ClinicalTrials.gov: NCT01548040 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Isometric Strength Test — -21.9; -31.9 Newton-metres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kneehab XP (Device); Quadriceps TENS (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Theragen Inc.
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Isometric Strength Test |
-21.9; -31.9 | — |
| SECONDARY Percentage of Patients With Positive PASS |
25.0; 16.4; 73.5; 61.2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01548040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.