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

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. In our hands 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 will be organized according to whether they need open or arthroscopic contracture release, then randomly assigned to one of two postoperative treatment groups: Experimental - CPM and Control - Physical Therapy. The subjects of this study will be followed for 12 months postoperatively. Throughout this 12 month period the impact/effectiveness of CPM versus 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.

• Procedure: Continuous Passive Motion
  Continuous passive motion.
• Procedure: Physical Therapy
  Physical therapy.

• Experimental: Continuous Passive Motion
  Subjects randomized to CPM therapy.
  Intervention: Procedure: Continuous Passive Motion
• Active Comparator: Physical Therapy
  Subjects randomized to physical therapy.
  Intervention: Procedure: Physical Therapy

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 an open or arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary (participants will be stratified according to open or arthroscopic surgery).

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. Preoperative neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
3. Neuromuscular disorder, including spasticity that might limit ability to completely participate in rehabilitation.
4. Psychiatric disorder, including spasticity that might limit ability to cooperate with rehabilitation.
5. Progressive inflammatory disease such as rheumatoid arthritis.