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Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study (CPM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Shawn W. O'Driscoll, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01420887
First received: July 13, 2011
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Elbow Injury
Procedure: Continuous Passive Motion
Procedure: Physical Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Recurrence of elbow contracture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subsequent injury or disease of the affected elbow [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: December 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Passive Motion
Subjects randomized to CPM therapy.
Procedure: Continuous Passive Motion
Continuous passive motion.
Active Comparator: Physical Therapy
Subjects randomized to physical therapy.
Procedure: Physical Therapy
Physical therapy.

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.
  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included, each patient must meet ALL of the following:

  1. Lack of elbow flexion and/or extension, with or without pain.
  2. The contracture must have been present for at least six months and failed to respond to non-surgical treatment.
  3. Surgery to be performed will be arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary

Exclusion Criteria:

  1. 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.
  2. progressive or recalcitrant neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
  3. Pre-existing factors that might limit ability to completely participate in rehabilitations such as neuromuscular or psychosocial condition.
  4. Progressive or recurrent contracture due to inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis or chondrolysis.
  5. Altered anatomy that might limit elbow motion, independent of the condition being treated, such as dysplasia, malunion, osteonecrosis, and congenital deformity.
  6. A reasonable restoration of motion and function cannot be expected.
  7. Inadequate postoperative regional anesthesia
  8. Intra-operative or postoperative complication that could affect outcome
  9. Injury or disease in the postoperative period that could affect elbow function
  10. Not possible to have postoperative physical therapy appointment
  11. Significant portion of the procedure performed in an open manner
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420887

Contacts
Contact: Tammy Olson 507-293-7613 olson.tammy@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tammy Olson    507-293-7613    olson.tammy@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Shawn O Driscoll, MD, PhD Mayo Clinic
  More Information

Responsible Party: Shawn W. O'Driscoll, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01420887     History of Changes
Other Study ID Numbers: 11-000601 
Study First Received: July 13, 2011
Last Updated: December 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
CPM
elbow joint surgery
continuous passive motion
Recovery after surgery to restore elbow motion

ClinicalTrials.gov processed this record on December 08, 2016