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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 : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
John Ryan, Ohio State University

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.

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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

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.



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407612


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: John Ryan, MD The Ohio State University Wexner Medical Center

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Responsible Party: John Ryan, Medical Doctor, Ohio State University
ClinicalTrials.gov Identifier: NCT03407612     History of Changes
Other Study ID Numbers: 2011H0416
First Posted: January 23, 2018    Key Record Dates
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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Pain, Postoperative
Femoracetabular Impingement
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases