Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

Not Applicable

Completed

• Conditions: Hip Labral Tear; Femoro Acetabular Impingement; Pain, Postoperative
• Interventions: Device: Continuous Passive Motion

• Registration Number: NCT03407612
• Lead Sponsor: Ohio State University

Brief Summary

The purpose of this study is to measure whether CPM (continuous passive motion) usage improves outcomes following arthroscopic hip surgery that includes labral repair. Investigators tested the hypothesis that CPM usage reduces pain levels and pain medication use and improves function in individuals who undergo hip arthroscopy.

Detailed Description

Subjects undergoing primary hip arthroscopy for acetabular labral repair were randomized to determine whether they would receive a CPM. Those subjects receiving a CPM were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks. The total number of pain medications and average pain scores over the two weeks, as well as Hip Outcome Score Activity of Daily Living (HOS ADL) scores at standard time points were compared via a two sample t-test and intention-to-treat analysis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02-15
• Primary Completion: 2015-06-25
• Study Completion: 2015-06-25
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-23
• Results First Submitted: 2018-04-05
• Results First Submitted QC: 2018-07-07
• Results First Posted: 2018-08-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• undergoing hip arthroscopy to repair a torn labrum

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Exclusion Criteria

• pregnancy
• revision surgery
• bilateral surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPM	Continuous Passive Motion	These subjects received a continuous passive motion (CPM) device and were instructed to use it for 4-6 hours daily throughout the first two postoperative weeks following their arthroscopic labral repair. They were provided adequate education on how to operate the device. The subjects recorded their average usage of the CPM, as well as their personal perception of the CPM, at the postoperative 2 day, 7 day, and 14 day marks.

Primary Outcome Measures

Name	Time	Method
Change in Patient Satisfaction and Functional Outcome	Baseline and 6 weeks, 12 weeks, and 6 months postoperatively	Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.

Secondary Outcome Measures

Name	Time	Method
Analgesic Usage	Initial two postoperative weeks	Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Pain Level	Initial two postoperative weeks	Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States