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Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

Primary Purpose

Femoro Acetabular Impingement, Pain, Postoperative, Hip Labral Tear

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Passive Motion
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoro Acetabular Impingement focused on measuring continuous passive motion device, HOS-ADL, hip arthroscopy

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

  • pregnancy
  • revision surgery
  • bilateral surgery

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CPM

No CPM

Arm Description

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.

No CPM was administered to these subjects.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic Usage
Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Pain Level
Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.

Full Information

First Posted
January 9, 2018
Last Updated
September 16, 2020
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03407612
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2013 (Actual)
Primary Completion Date
June 25, 2015 (Actual)
Study Completion Date
June 25, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoro Acetabular Impingement, Pain, Postoperative, Hip Labral Tear
Keywords
continuous passive motion device, HOS-ADL, hip arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPM
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No CPM
Arm Type
No Intervention
Arm Description
No CPM was administered to these subjects.
Intervention Type
Device
Intervention Name(s)
Continuous Passive Motion
Intervention Description
CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
Primary Outcome Measure Information:
Title
Change in Patient Satisfaction and Functional Outcome
Description
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.
Time Frame
Baseline and 6 weeks, 12 weeks, and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Analgesic Usage
Description
Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Time Frame
Initial two postoperative weeks
Title
Pain Level
Description
Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.
Time Frame
Initial two postoperative weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: undergoing hip arthroscopy to repair a torn labrum Exclusion Criteria: pregnancy revision surgery bilateral surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ryan, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

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