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

Therapuetic Areas:Other
Age Range:13 - Any
Start Date:December 2, 2016
End Date:April 2020
Contact:Tammy Olson

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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.

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.

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

12. Women that know they are pregnant or breastfeeding

13. Current or prior septic arthritis
We found this trial at
200 First Street SW
Rochester, Minnesota 55905
Phone: 507-293-7613
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Rochester, MN
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