Knee ArthroplastyNCT02339831
Active Versus Passive Motion Device Following Knee Replacement Surgery
A study testing CAMOPED and CPM passive motion device in people with Knee Arthroplasty, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- CAMOPED and CPM passive motion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
About this study
Official title: A Prospective, Randomized, Controlled, Single Center Study Evaluating the Clinical Performance of CAMOPED Following Knee Replacement
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.
Read the 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.
- Conditions
- Knee Arthroplasty
- Being tested
- CAMOPED, CPM passive motion device
- Keywords
- Knee, Arthroplasty, CPM, Camoped, Active vs Passive Motion Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMOPEDDevice
Camoped given after surgery
CPM passive motion deviceDevice
passive motion device given after surgery
| Study group | Role | What they receive |
|---|---|---|
| active motion device | Active comparator | 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. Receives: Device: CAMOPED |
| CPM passive motion device | Active comparator | 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. Receives: Device: CPM passive motion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Functional Outcome Strength
Quadriceps strength measurements using a hand held dynamometer
Measured: 4-6 weeks post-op
Early Functional Outcome by Sit to Stand Test
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".
Measured: 4-6 weeks post-op
Early Functional Outcome Proprioception
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.
Measured: 4-6 weeks post-op
Early Function Outcome Kinesthesia
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.
Measured: 4-6 weeks post op
Early Functional Outcome Knee Flexion
Knee-flexion was measured using an 8-inch goniometer.
Measured: 4-6 weeks post op
Secondary outcomes (4)
General Mental Orthopaedic Outcome Measures
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.
Measured: 4-6 weeks post-op
General Activity Orthopaedic Outcome Measures
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.
Measured: 4-6 weeks post-op
General Functional Orthopaedic Outcome Measures
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.
Measured: 4-6 weeks post-op
General Pain
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".
Measured: 4-6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startMar 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The New England Baptist Hospital
- Responsible party
- Principal investigator, Wolfgang Fitz, Brigham and Women's Hospital
- Investigators
- Wolfgang Fitz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339831
- Sponsor's protocol ID
- WFCAMCPM1
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2015
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 15866968Harvey 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.
PubMed 20238330Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998 Oct;33(4):323-7.
PubMed 16558529Gstoettner 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.
PubMed 20801047Wada 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.
PubMed 12360022
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Single Center Study Evaluating the Clinical Performance of CAMOPED Following Knee Replacement
- ClinicalTrials.gov ID
- NCT02339831
- Acronym / sponsor ID
- WFCAMCPM1
- Conditions
- Knee Arthroplasty
- Keywords
- Knee, Arthroplasty, CPM, Camoped, Active vs Passive Motion Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The New England Baptist Hospital
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active motion device | Active comparator | Device: CAMOPEDAn 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. |
| CPM passive motion device | Active comparator | Device: CPM passive motion deviceA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • At least 18 years of age
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMOPEDCamoped given after surgery | Device | active motion device |
| CPM passive motion devicepassive motion device given after surgery | Device | CPM passive motion device |
Primary outcome
Early Functional Outcome Strength
Time frame: 4-6 weeks post-op
Quadriceps strength measurements using a hand held dynamometer
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".
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.
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.
Early Functional Outcome Knee Flexion
Time frame: 4-6 weeks post op
Knee-flexion was measured using an 8-inch goniometer.
4 secondary outcomes
General Mental Orthopaedic Outcome Measures
Time frame: 4-6 weeks post-op
General Activity Orthopaedic Outcome Measures
Time frame: 4-6 weeks post-op
General Functional Orthopaedic Outcome Measures
Time frame: 4-6 weeks post-op
General Pain
Time frame: 4-6 weeks post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15866968Mizner 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.
- Background: PubMed 20238330Harvey 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.
- Background: PubMed 16558529Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998 Oct;33(4):323-7.
- Background: PubMed 20801047Gstoettner 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.
- Background: PubMed 12360022Wada 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Fitz, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CAMOPED and CPM passive motion device in people with Knee Arthroplasty, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Functional Outcome Strength (time frame: 4-6 weeks post-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339831, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.