NCT03407612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 2, 2018

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

January 9, 2018

Results QC Date

April 5, 2018

Last Update Submit

September 16, 2020

Conditions

Keywords

continuous passive motion deviceHOS-ADLhip arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 6 weeks, 12 weeks, and 6 months postoperatively

Secondary Outcomes (2)

  • Analgesic Usage

    Initial two postoperative weeks

  • Pain Level

    Initial two postoperative weeks

Study Arms (2)

CPM

ACTIVE COMPARATOR

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

No CPM

NO INTERVENTION

No CPM was administered to these subjects.

Interventions

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

CPM

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • undergoing hip arthroscopy to repair a torn labrum

You may not qualify if:

  • pregnancy
  • revision surgery
  • bilateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Femoracetabular ImpingementPain, Postoperative

Interventions

Motion Therapy, Continuous Passive

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMusculoskeletal Manipulations

Results Point of Contact

Title
Maria Munsch
Organization
Jameson Crane Sports Medicine Institute

Study Officials

  • John Ryan, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 23, 2018

Study Start

February 15, 2013

Primary Completion

June 25, 2015

Study Completion

June 25, 2015

Last Updated

October 8, 2020

Results First Posted

August 2, 2018

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations