- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02339831
Active Versus Passive Motion Device Following Knee Replacement Surgery
A Prospective, Randomized, Controlled, Single Center Study Evaluating the Clinical Performance of CAMOPED Following Knee Replacement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. 110 patients will be randomized during the course of the study. Participation lasts approximately 4 weeks. Data for patients who begin the trial, but choose to drop out or are lost to follow up will not be included in analysis.
Patients who have elected to undergo surgery with one of the PIs, either a total knee replacement with Dr. Richard Scott or a partial knee replacement with Dr. Wolfgang Fitz, will be informed about the study and offered participation if they meet eligibility criteria. The PI will obtain written consent in the office for those who choose to participate. For participants, demographic data including height, weight, BMI, age and sex will be collected. Additionally, sit-to-stand, knee flexion, proprioception, strength and balance testing will be performed in the office by a physical therapist. Participant responses to the SF-36 physical and mental health surveys, knee function score, KSS and WOMAC questionnaires will also be collected.
Patients will be randomized to receive either the Camoped or CPM device after surgery. Patients will receive the device and its protocol for usage in the hospital following surgery. They will use the device for the duration of their hospital stay, and then take the device home. At home, patients will be asked to keep a daily diary tracking device usage as well as daily pain and medication intake. These results will be compared as part of the study analysis.
When patients return for their follow-up appointment four weeks after surgery, demographic data including height, weight, BMI, age and sex will be collected. Additionally, sit-to-stand, knee flexion, proprioception, strength and balance testing will be performed in the office. Participant responses to the SF-36 physical and mental health surveys, knee function score, KSS and WOMAC questionnaires will also be collected. These measures will be compared to the preoperative results.
Two-sample t-tests will be used to analyze the similarity between the two treatment groups before the intervention and to assess any differences afterwards. The Wilcoxon-Mann Whitney test will be performed as a non-parametric alternative to t-testing for any data sets found to be non-normal.
Data collection and management will be the responsibility of the PIs. All adverse events will be reported as necessary.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active motion device
An active motion device (CAM) known as a CAMOPED was given after surgery.
The device was used for 3 sessions of 20 minutes for 3 weeks.
|
Camoped given after surgery
|
Active Comparator: CPM passive motion device
A continuous passive motion device (CPM) given after surgery.
The device bends and moved the knee passively.
It was used for 4 hours daily for 3 weeks.
|
passive motion device given after surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Functional Outcome Strength
Time Frame: 4-6 weeks post-op
|
Quadriceps strength measurements using a hand held dynamometer
|
4-6 weeks post-op
|
Early Functional Outcome by Sit to Stand Test
Time Frame: 4-6 weeks post-op
|
Sit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded.
Patient was asked to sit with back against chair and told to stand up without using any support.
Arms were suggested to be folded in front of chest.
Time started with recorded said "Go".
|
4-6 weeks post-op
|
Early Functional Outcome Proprioception
Time Frame: 4-6 weeks post-op
|
Biodex Balance Machine Score.
The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees.
All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position.
The normal range for adults 54-71 is 1.79 - 3.35.
Lower values indicate better/greater stability.
|
4-6 weeks post-op
|
Early Function Outcome Kinesthesia
Time Frame: 4-6 weeks post op
|
Kinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes.
The differences were recorded in degrees using an 8-inch goniometer.
|
4-6 weeks post op
|
Early Functional Outcome Knee Flexion
Time Frame: 4-6 weeks post op
|
Knee-flexion was measured using an 8-inch goniometer.
|
4-6 weeks post op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Mental Orthopaedic Outcome Measures
Time Frame: 4-6 weeks post-op
|
Short form 36 mental health score.
The scale is measured from 0-100.
0 is the lowest or worst possible level of functioning and 100 is the highest or best possible level of functioning.
|
4-6 weeks post-op
|
General Activity Orthopaedic Outcome Measures
Time Frame: 4-6 weeks post-op
|
Western Ontario and McMaster Universities Arthritis Index is measured on a scale of 0-68.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
|
4-6 weeks post-op
|
General Functional Orthopaedic Outcome Measures
Time Frame: 4-6 weeks post-op
|
Knee society score is an objective patient reported outcome survey to measure a patient's functional ability before and after knee arthroplasty.
It is measured on a scale of 1-100.
A score between 80-100 indicated excellent functioning, a score between 70-79 indicates good functioning, a score between 60-69 indicates fair functioning, and a score below 60 indicates poor functioning.
|
4-6 weeks post-op
|
General Pain
Time Frame: 4-6 weeks post-op
|
Self-reported total pain medication consumption was recorded by patients and at the end of the four-week period converted into standard units for comparison as "oxycodone equivalent dosage".
|
4-6 weeks post-op
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
- Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004260. doi: 10.1002/14651858.CD004260.pub2.
- Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998 Oct;33(4):323-7.
- Gstoettner M, Raschner C, Dirnberger E, Leimser H, Krismer M. Preoperative proprioceptive training in patients with total knee arthroplasty. Knee. 2011 Aug;18(4):265-70. doi: 10.1016/j.knee.2010.05.012. Epub 2010 Aug 30.
- Wada M, Kawahara H, Shimada S, Miyazaki T, Baba H. Joint proprioception before and after total knee arthroplasty. Clin Orthop Relat Res. 2002 Oct;(403):161-7. doi: 10.1097/00003086-200210000-00024.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WFCAMCPM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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