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Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair

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ClinicalTrials.gov Identifier: NCT03407612
Recruitment Status : Completed
First Posted : January 23, 2018
Results First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
John Ryan, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Femoro Acetabular Impingement
Pain, Postoperative
Hip Labral Tear
Intervention Device: Continuous Passive Motion
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CPM Used No CPM Used
Hide 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
Arm/Group Title CPM Used No CPM Used Total
Hide 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 Number of Baseline Participants 19 23 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 23 participants 42 participants
36.2  (10.7) 29.5  (11.1) 32.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 42 participants
Female
18
  94.7%
20
  87.0%
38
  90.5%
Male
1
   5.3%
3
  13.0%
4
   9.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 23 participants 42 participants
19 23 42
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 23 participants 42 participants
27.5  (7.0) 25.1  (4.6) 26.2  (5.8)
Hand Dominance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 42 participants
Right Handed
11
  57.9%
13
  56.5%
24
  57.1%
Left Handed
8
  42.1%
10
  43.5%
18
  42.9%
1.Primary Outcome
Title Change in Patient Satisfaction and Functional Outcome
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPM Used No CPM Used
Hide 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.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide 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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide 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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide 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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Analgesic Usage
Hide Description Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Time Frame Initial two postoperative weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPM Used No CPM Used
Hide 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.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: morphine equivalent doses
239  (269) 330  (227)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPM Used, No CPM Used
Comments [Not Specified]
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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Pain Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPM Used No CPM Used
Hide 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.
Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.94  (2.0) 4.23  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPM Used, No CPM Used
Comments [Not Specified]
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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months from operation date
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPM Used No CPM Used
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CPM Used No CPM Used
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CPM Used No CPM Used
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Munsch
Organization: Jameson Crane Sports Medicine Institute
Phone: 4123357979
Responsible Party: John Ryan, Ohio State University
ClinicalTrials.gov Identifier: NCT03407612     History of Changes
Other Study ID Numbers: 2011H0416
First Submitted: January 9, 2018
First Posted: January 23, 2018
Results First Submitted: April 5, 2018
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018