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Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

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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:
Information provided by (Responsible Party):
John Ryan, Ohio State University

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 23, 2018
Results First Submitted Date  ICMJE April 5, 2018
Results First Posted Date  ICMJE August 2, 2018
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE February 15, 2013
Actual Primary Completion Date June 25, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: January 16, 2018)
Change in Patient Satisfaction [ Time Frame: Baseline and 6 months postoperatively ]
HOS ADL completed at specific time points
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Femoro Acetabular Impingement
  • Pain, Postoperative
  • Hip Labral Tear
Intervention  ICMJE Device: Continuous Passive Motion
CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2018)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2015
Actual Primary Completion Date June 25, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

  • pregnancy
  • revision surgery
  • bilateral surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03407612
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party John Ryan, Ohio State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ohio State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Ryan, MD The Ohio State University Wexner Medical Center
PRS Account Ohio State University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP