Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

NCT ID: NCT03407612

Last Updated: 2020-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-15

Study Completion Date

2015-06-25

Brief Summary

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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

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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.

Conditions

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Femoro Acetabular Impingement Pain, Postoperative Hip Labral Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Continuous Passive Motion

Intervention Type DEVICE

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

No CPM

No CPM was administered to these subjects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous Passive Motion

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria

* pregnancy
* revision surgery
* bilateral surgery
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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John Ryan

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2011H0416

Identifier Type: -

Identifier Source: org_study_id

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