Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Femoro Acetabular Impingement; Hip Labral Tear
• Intervention / Treatment: Device: Continuous Passive Motion

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

• pregnancy
• revision surgery
• bilateral surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Usage	Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications	Initial two postoperative weeks
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2013
• Primary Completion (Actual): June 25, 2015
• Study Completion (Actual): June 25, 2015

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: hip arthroscopy; continuous passive motion device; HOS-ADL
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Pain, Postoperative; Femoracetabular Impingement
• Other Study ID Numbers: 2011H0416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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