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

Tracking Information

• First Submitted Date: January 9, 2018
• First Posted Date: January 23, 2018
• Results First Submitted Date: April 5, 2018
• Results First Posted Date: August 2, 2018
• Last Update Posted Date: October 8, 2020
• Actual Study Start Date: February 15, 2013
• Actual Primary Completion Date: June 25, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2018)

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.

Original Primary Outcome Measures (submitted: January 16, 2018)

Change in Patient Satisfaction [ Time Frame: Baseline and 6 months postoperatively ]

HOS ADL completed at specific time points

Current Secondary Outcome Measures (submitted: July 7, 2018)

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

Original Secondary Outcome Measures (submitted: January 16, 2018)

• Analgesic Usage [ Time Frame: Baseline and two postoperative weeks ]
  Change in analgesic usage measured via the number of consumed analgesic medications
• Pain Level [ Time Frame: Baseline and two postoperative weeks ]
  Change in pain level measured on a 0-10 Likert scale, with higher scores representing higher pain levels.
• Change in Functional Outcome [ Time Frame: Baseline and 6 months postoperatively ]
  HOS ADL completed at specific time points

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair
• Official Title: The Effect of Continuous Passive Motion on Pain Control Following Hip Arthroscopy
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Device: Continuous Passive Motion

CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.

Study Arms

• 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.
  Intervention: Device: Continuous Passive Motion
• No Intervention: No CPM
  No CPM was administered to these subjects.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 16, 2018): 54
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 25, 2015
• Actual Primary Completion Date: June 25, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

• pregnancy
• revision surgery
• bilateral surgery

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 50 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03407612
• Other Study ID Numbers: 2011H0416
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: John Ryan, Ohio State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ohio State University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Ohio State University
• Verification Date: September 2020