Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01420887
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2011-07-13
Brief Title:
Preservation of Joint Function Using Postoperative Continuous Passive Motion CPM A Pilot Study
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Preservation of Joint Function Using Postoperative Continuous Passive Motion CPM A Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPM
Brief Summary:
This pilot study is designed to determine if the rehabilitative benefits of continuous passive motion CPM will help preserverestore 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
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 activitywork 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 preserverestore 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 impacteffectiveness 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None