Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

• ClinicalTrials.gov Identifier: NCT03407612
• Recruitment Status: Completed
• First Posted: January 23, 2018
• Results First Posted: August 2, 2018
• Last Update Posted: October 8, 2020
• Sponsor: Ohio State University
• Information provided by (Responsible Party): John Ryan, Ohio State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Femoro Acetabular Impingement; Pain, Postoperative; Hip Labral Tear	Device: Continuous Passive Motion	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Continuous Passive Motion on Pain Control Following Hip Arthroscopy
• Actual Study Start Date: February 15, 2013
• Actual Primary Completion Date: June 25, 2015
• Actual Study Completion Date: June 25, 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CPM; 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.	Device: Continuous Passive Motion; CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
No Intervention: No CPM; No CPM was administered to these subjects.

Outcome Measures

Primary Outcome Measures :

1. Change in Patient Satisfaction and Functional Outcome [ Time Frame: 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 :

1. Analgesic Usage [ Time Frame: Initial two postoperative weeks ]
   Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
2. Pain Level [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

• pregnancy
• revision surgery
• bilateral surgery

Contacts and Locations

Locations

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43212

Sponsors and Collaborators

Ohio State University

Investigators

• Principal Investigator: John Ryan, MD; The Ohio State University Wexner Medical Center

More Information

• Responsible Party: John Ryan, Medical Doctor, Ohio State University
• ClinicalTrials.gov Identifier: NCT03407612
• Other Study ID Numbers: 2011H0416
• First Posted: January 23, 2018
• Results First Posted: August 2, 2018
• Last Update Posted: October 8, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by John Ryan, Ohio State University:

continuous passive motion device; HOS-ADL; hip arthroscopy

Additional relevant MeSH terms:

Femoracetabular Impingement; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases