- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420887
Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study (CPM)
July 1, 2020 updated by: Shawn W. O'Driscoll, Mayo Clinic
This pilot study is designed to determine if the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after the surgical release of elbow contractures better than standard physiotherapy and static splinting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Elbow stiffness and reduced motion commonly occur after elbow injury or surgery.
With traumatic injuries to the elbow, contractures are a common complication.
Indeed, they are expected in most cases.
For patients with these injuries who are otherwise healthy, active and require the restoration of full function in order to return to their previous level of activity/work, this reduced motion can be especially problematic and even debilitating.
The investigators have found and published that most patients treated with postoperative Continuous Passive Motion following surgical repair of their stiffness have been able to recover all or nearly all of their prior elbow mobility and function.
Though CPM has been in clinical use for decades, a prospective randomized clinical trial has never been published proving its effectiveness.
The investigators believe and intend to show in this study that the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after stiffness is surgically repaired.
Specific Aim 1: To demonstrate that postoperative use of CPM enhances tissue healing and hastens recovery following surgical release of elbow contracture.
Specific Aim 2: To demonstrate that postoperative use of CPM improves ultimate function following surgical release of elbow contracture.
Specific Aim 3: To demonstrate that CPM is a cost-efficient treatment following surgical release of elbow contracture.
Study Design: 50 patients who require arthroscopic contracture release, will be randomly assigned to one of two postoperative treatment groups: Experimental - CPM and Control - Physical Therapy.
Participants of this study will be followed for 12 months postoperatively.
Throughout this 12 month period the impact/effectiveness of CPM vs Physical Therapy will be evaluated by assessing functional status, pain, mobility, general health related quality of life, utility, and societal cost-effectiveness.
In line with the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, this study will help anyone with elbow injuries that result in stiffness and loss of motion.
Such a study has the advantage of being highly translational with the potential to have an immediate impact on patient treatment and care.
The findings from this study will be able to help patients immediately and ensure that the principals of Evidence Based Medicine are applied to patients with these types of elbow injuries and that they receive the treatment they need for the best possible recovery based on hard evidence and scientific facts.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
To be included, each patient must meet ALL of the following:
- Lack of elbow flexion and/or extension, with or without pain.
- The contracture must have been present for at least six months and failed to respond to non-surgical treatment.
- Surgery to be performed will be arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary
Exclusion Criteria:
- Contraindication to use of CPM or regional brachial plexus block, such as bleeding diathesis, use of anticoagulants or severe restriction in shoulder range of movement.
- Progressive or recalcitrant neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
- Pre-existing factors that might limit ability to completely participate in rehabilitations such as neuromuscular or psychosocial condition.
- Progressive or recurrent contracture due to inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis or chondrolysis.
- Altered anatomy that might limit elbow motion, independent of the condition being treated, such as dysplasia, malunion, osteonecrosis, and congenital deformity.
- A reasonable restoration of motion and function cannot be expected.
- Inadequate postoperative regional anesthesia
- Intra-operative or postoperative complication that could affect outcome
- Injury or disease in the postoperative period that could affect elbow function
- Not possible to have postoperative physical therapy appointment
- Significant portion of the procedure performed in an open manner
- Women that know they are pregnant or breastfeeding
- Current or prior septic arthritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: Continuous Passive Motion
Subjects randomized to CPM therapy.
|
Continuous passive motion.
|
Active Comparator: Physical Therapy
Subjects randomized to physical therapy.
|
Physical therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of elbow contracture
Time Frame: 1 year
|
There will be an 80% statistical power to detect a difference of 2 points in the pre-surgery to post-surgery change in VAS pain between subjects in the two study arms.
Similarly, there will be an 80% power to detect a difference of 16 degrees in the pre-surgery to post-surgery change in total arc of motion between the two study groups.
There will be 80% power to detect a difference of at least 9 points on the pre-surgery to post-surgery difference in the DASH score.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subsequent injury or disease of the affected elbow
Time Frame: 1 year
|
There will be an 80% statistical power to detect a difference of 2 points in the pre-surgery to post-surgery change in VAS pain between subjects in the two study arms.
Similarly, there will be an 80% power to detect a difference of 16 degrees in the pre-surgery to post-surgery change in total arc of motion between the two study groups.
There will be 80% power to detect a difference of at least 9 points on the pre-surgery to post-surgery difference in the DASH score.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shawn O Driscoll, MD, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2016
Primary Completion (Actual)
May 19, 2020
Study Completion (Actual)
May 19, 2020
Study Registration Dates
First Submitted
July 13, 2011
First Submitted That Met QC Criteria
August 18, 2011
First Posted (Estimate)
August 22, 2011
Study Record Updates
Last Update Posted (Actual)
July 2, 2020
Last Update Submitted That Met QC Criteria
July 1, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-000601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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