Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

Pain, Postoperative Clinical Trial

Official title:

The Effect of Continuous Passive Motion on Pain Control Following Hip Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407612
• Other study ID #: 2011H0416
• Status: Completed
• Phase: N/A
• Start date: February 15, 2013
• Est. completion date: June 25, 2015

Study information

• Verified date: September 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 25, 2015
• Est. primary completion date: June 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

• pregnancy

• revision surgery

• bilateral surgery

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Hip Labral Tear
• Pain, Postoperative

Intervention

Device:
• Continuous Passive Motion
CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Satisfaction and Functional Outcome	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.	Baseline and 6 weeks, 12 weeks, and 6 months postoperatively
Secondary	Analgesic Usage	Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications	Initial two postoperative weeks
Secondary	Pain Level	Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.	Initial two postoperative weeks