N/A
N=110
Active Versus Passive Motion Device Following Knee Replacement Surgery
Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT02339831 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Early Functional Outcome Strength — 12.02; 11.60 newton meter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAMOPED (Device); CPM passive motion device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Functional Outcome Strength |
12.02; 11.60 | — |
| PRIMARY Early Functional Outcome by Sit to Stand Test |
2.83; 3.43 | — |
| PRIMARY Early Functional Outcome Proprioception |
3.11; 2.98 | — |
| PRIMARY Early Function Outcome Kinesthesia |
2.90; 2.98 | — |
| PRIMARY Early Functional Outcome Knee Flexion |
104.3; 101.0 | — |
| SECONDARY General Mental Orthopaedic Outcome Measures |
40.2; 39.4 | — |
| SECONDARY General Activity Orthopaedic Outcome Measures |
45.8; 50.2 | — |
| SECONDARY General Functional Orthopaedic Outcome Measures |
64.7; 62.6 | — |
| SECONDARY General Pain |
471.77; 346.97 | — |
Summary
The purpose of this study is to determine how well an active motion device, Camoped, works compared to a continuous passive motion device, CPM, for rehabilitation after partial or total knee replacement. It is hypothesized that the Camoped active motion device will provide outcomes equal to or superior than the CPM. Patients undergoing either partial or total knee replacement will be given the opportunity to participate. If they elect to participate, preoperative data will be collected including demographics, measures of strength, balance and knee bending, as well as surveys regarding current physical and mental health, as well as knee function. After surgery, patients will be randomly selected to receive either the Camoped or the CPM for use during their rehabilitation. After discharge, participants will be asked to maintain a daily diary tracking their use of the assigned device, as well as their daily pain levels. At a visit 4 weeks after surgery, participants will be asked to complete a series of surveys pertaining to their health and knee function, as well as to perform tests of strength, balance and knee bending. These results will be used to determine if one device produces superior rehabilitation results following total or partial knee replacement surgery.
Eligibility Criteria
Inclusion Criteria
- • At least 18 years of age
- Undergoing unilateral knee replacement
- If female, not pregnant
- Agree to participate in the follow-up appointment
- Understand and sign the informed consent form
Exclusion Criteria
- Bilateral UKA or TKA planned
- Cannot use non-operated leg post-operatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
- Loss of sensation of/in? operated or non-operated leg
- Received investigational articles <30 days prior to enrollment or was currently receiving investigational products or devices.
- Below or above knee amputations of non-operated leg
- Below knee amputation of operated side
- Chronic pain syndrome with inability to walk and/or use active or passive motion device post-operatively
- Patients taking chronic narcotics and/or are taking more than 10mg codeine per day, or any Hydrocodone, more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
- Patients involved in pain clinics for chronic pain, or pain that is not related to the knee
- Diagnosis of knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout
- Inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemiparalysis)
Data sourced from ClinicalTrials.gov (NCT02339831). 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.