Trial Outcomes & Findings for Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair (NCT NCT03407612)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

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

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	CPM Used 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 Used No CPM was administered to these subjects.
Overall Study STARTED	19	23
Overall Study COMPLETED	19	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPM Used n=19 Participants 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 Used n=23 Participants No CPM was administered to these subjects.	Total n=42 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 10.7 • n=19 Participants	29.5 years STANDARD_DEVIATION 11.1 • n=23 Participants	32.5 years STANDARD_DEVIATION 11.3 • n=42 Participants
Sex: Female, Male Female	18 Participants n=19 Participants	20 Participants n=23 Participants	38 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=19 Participants	3 Participants n=23 Participants	4 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	19 participants n=19 Participants	23 participants n=23 Participants	42 participants n=42 Participants
BMI	27.5 kg/m^2 STANDARD_DEVIATION 7.0 • n=19 Participants	25.1 kg/m^2 STANDARD_DEVIATION 4.6 • n=23 Participants	26.2 kg/m^2 STANDARD_DEVIATION 5.8 • n=42 Participants
Hand Dominance Right Handed	11 Participants n=19 Participants	13 Participants n=23 Participants	24 Participants n=42 Participants
Hand Dominance Left Handed	8 Participants n=19 Participants	10 Participants n=23 Participants	18 Participants n=42 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CPM Used n=19 Participants 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 Used n=23 Participants No CPM was administered to these subjects.
Change in Patient Satisfaction and Functional Outcome Preoperative	64.5 units on a scale Standard Deviation 11.6	62.7 units on a scale Standard Deviation 15.0
Change in Patient Satisfaction and Functional Outcome 6 weeks postoperative	74.6 units on a scale Standard Deviation 14.8	72.8 units on a scale Standard Deviation 12.5
Change in Patient Satisfaction and Functional Outcome 12 weeks postoperative	81.1 units on a scale Standard Deviation 14.6	81.5 units on a scale Standard Deviation 11.4
Change in Patient Satisfaction and Functional Outcome 6 months postoperative	81.9 units on a scale Standard Deviation 16.4	82.8 units on a scale Standard Deviation 12.8
Change in Patient Satisfaction and Functional Outcome Improvement	17.0 units on a scale Standard Deviation 16.0	20.2 units on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: Initial two postoperative weeks

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

Outcome measures

Outcome measures
Measure	CPM Used n=19 Participants 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 Used n=23 Participants No CPM was administered to these subjects.
Analgesic Usage	239 morphine equivalent doses Standard Deviation 269	330 morphine equivalent doses Standard Deviation 227

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CPM Used n=19 Participants 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 Used n=23 Participants No CPM was administered to these subjects.
Pain Level	2.94 units on a scale Standard Deviation 2.0	4.23 units on a scale Standard Deviation 2.0

Adverse Events

CPM Used

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No CPM Used

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Munsch

Jameson Crane Sports Medicine Institute

Phone: 614-293-3600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place