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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01420887 |
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Date of registration:
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13/07/2011 |
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Primary sponsor: |
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Public title:
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Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study
CPM |
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Scientific title:
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Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01420887 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Tyson L. Scrabeck |
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Address:
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Telephone:
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507-538-1016 |
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Email:
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scrabeck.tyson@mayo.edu |
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Affiliation:
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Name:
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Shawn O Driscoll, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Elbow Injury
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Intervention(s)
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Procedure: Continuous Passive Motion
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Procedure: Physical Therapy
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Primary Outcome(s)
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Recurrence of elbow contracture
[Time Frame: 1 year]
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Secondary Outcome(s)
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Subsequent injury or disease of the affected elbow
[Time Frame: 1 year]
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Secondary ID(s)
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11-000601
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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