Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03407612
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.3
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Femoro Acetabular Impingement; Pain, Postoperative; Hip Labral Tear	Device: Continuous Passive Motion	N/A

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.

Study Design

• Study Type: Interventional
• 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: Feb 15, 2013
• Actual Primary Completion Date: Jun 25, 2015
• Actual Study Completion Date: Jun 25, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Analgesic Usage [Initial two postoperative weeks]

   Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications

2. 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 Criteria

Criteria

• Ages Eligible for Study: 14 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• undergoing hip arthroscopy to repair a torn labrum

Exclusion Criteria:

• pregnancy

• revision surgery

• bilateral surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43212

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: John Ryan, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Ryan, Medical Doctor, Ohio State University
• ClinicalTrials.gov Identifier: NCT03407612
• Other Study ID Numbers: 2011H0416
• First Posted: Jan 23, 2018
• Last Update Posted: Oct 8, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by John Ryan, Medical Doctor, Ohio State University: continuous passive motion device; HOS-ADL; hip arthroscopy
• Additional relevant MeSH terms: Femoracetabular Impingement; Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	CPM Used	No CPM Used
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.	No CPM was administered to these subjects.
Period Title: Overall Study
STARTED	19	23
COMPLETED	19	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CPM Used	No CPM Used	Total
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.	No CPM was administered to these subjects.	Total of all reporting groups
Overall Participants	19	23	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (10.7)	29.5 (11.1)	32.5 (11.3)
Sex: Female, Male (Count of Participants)
Female	18 94.7%	20 87%	38 90.5%
Male	1 5.3%	3 13%	4 9.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%	23 100%	42 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.5 (7.0)	25.1 (4.6)	26.2 (5.8)
Hand Dominance (Count of Participants)
Right Handed	11 57.9%	13 56.5%	24 57.1%
Left Handed	8 42.1%	10 43.5%	18 42.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPM Used	No CPM Used
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.	No CPM was administered to these subjects.
Measure Participants	19	23
Preoperative	64.5 (11.6)	62.7 (15.0)
6 weeks postoperative	74.6 (14.8)	72.8 (12.5)
12 weeks postoperative	81.1 (14.6)	81.5 (11.4)
6 months postoperative	81.9 (16.4)	82.8 (12.8)
Improvement	17.0 (16.0)	20.2 (15.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments	This analysis considers the baseline HOS-ADL measures.
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments	This analysis considers the 6 week postoperative HOS-ADL measures.
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments	This analysis considers the 12 week postoperative HOS-ADL measures.
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments	This analysis considers the 6 month postoperative HOS-ADL measures.
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Analgesic Usage
Description	Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Time Frame	Initial two postoperative weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPM Used	No CPM Used
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.	No CPM was administered to these subjects.
Measure Participants	19	23
Mean (Standard Deviation) [morphine equivalent doses]	239 (269)	330 (227)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPM Used	No CPM Used
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.	No CPM was administered to these subjects.
Measure Participants	19	23
Mean (Standard Deviation) [units on a scale]	2.94 (2.0)	4.23 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CPM Used, No CPM Used
	Comments
	Type of Statistical Test	Equivalence
	Comments	p < 0.05 required for groups to have non-equivalent results.
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	6 months from operation date
Arm/Group Title	CPM Used		No CPM Used
Arm/Group 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. Continuous Passive Motion: CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.		No CPM was administered to these subjects.
All Cause Mortality
	CPM Used		No CPM Used
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CPM Used		No CPM Used
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	CPM Used		No CPM Used
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.