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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 11-000601
    NCT ID: NCT01420887
    Sponsor Protocol Number: 11-000601

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

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

  1. Has had a functional assessment of the elbow using a standard BTE device
  2. Lack of elbow flexion and/or extension, with or without pain.
  3. The contracture must have been present for at least six months and failed to respond to non-surgical treatment.
  4. Surgery to be performed will be an arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary (participants will be stratified according to 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
  6. Current or prior septic arthritis
  7. Pregnant or breastfeeding

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shawn O'Driscoll, M.D., Ph.D.

Open for enrollment

Contact information:

Tammy Olson

(507)293-7613

MayoElbowStudy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20112224

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