Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

NCT03407612 — Not applicable, Completed, 54 participants, Ohio State University

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

Registry	NCT03407612
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	54 (Actual)
Sponsor	Ohio State University (Other)
Conditions	Femoro Acetabular Impingement, Pain, Postoperative, Hip Labral Tear
Interventions	Continuous Passive Motion (Device)
Dates	start 2013-02-15, primary completion 2015-06-25, completion 2015-06-25, first posted 2018-01-23, last updated 2020-10-08
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
CPM	Active comparator	Device: Continuous Passive Motion	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	No intervention		No CPM was administered to these subjects.

Continuous Passive Motion (Device): CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.

+Outcome measures

Primary outcomes

Change in Patient Satisfaction and Functional Outcome [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 outcomes

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

+Eligibility

Sex: All, ages: 14 Years to 50 Years

Inclusion Criteria:

* undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

* pregnancy
* revision surgery
* bilateral surgery

+Posted results

Participant flow

Milestone	CPM Used	No CPM Used
Started	19	23
Completed	19	23
Not completed	0	0

Outcome results

Change in Patient Satisfaction and Functional Outcome (Primary), Mean, units on a scale: CPM Used 64.5 +/- 11.6; No CPM Used 62.7 +/- 15.0 (p 0.67)
Analgesic Usage (Secondary), Mean, morphine equivalent doses: CPM Used 239 +/- 269; No CPM Used 330 +/- 227 (p 0.25)
Pain Level (Secondary), Mean, units on a scale: CPM Used 2.94 +/- 2.0; No CPM Used 4.23 +/- 2.0 (p 0.04)

Adverse events

Time frame: 6 months from operation date

Arm	Deaths	Serious adverse events	Other adverse events
CPM Used	0	0/19 (0.0%)	0/19 (0.0%)
No CPM Used	0	0/23 (0.0%)	0/23 (0.0%)

+Locations (1)

Facility	City	Country	Status
The Ohio State University Wexner Medical Center	Columbus, Ohio	United States

+Investigators

John Ryan, MD, Principal investigator, Ohio State University

My Notes

Public

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