An interventional study of Continuous Passive Motion in Femoro Acetabular Impingement, Pain, Postoperative and Hip Labral Tear, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 was administered to these subjects.
CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
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.
Time frame: Baseline and 6 weeks, 12 weeks, and 6 months postoperatively
Analgesic Usage
Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Time frame: Initial two postoperative weeks
Pain Level
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
| Milestone | CPM Used | No CPM Used |
|---|---|---|
| Started | 19 | 23 |
| Completed | 19 | 23 |
| Not completed | 0 | 0 |
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.
| units on a scale | CPM Used | No CPM Used |
|---|---|---|
| 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 |
Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
| morphine equivalent doses | CPM Used | No CPM Used |
|---|---|---|
| Analgesic Usage | 239 ± 269 | 330 ± 227 |
Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.
| units on a scale | CPM Used | No CPM Used |
|---|---|---|
| Pain Level | 2.94 ± 2.0 | 4.23 ± 2.0 |
Collected over 6 months from operation date. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPM Used | — | 0/19 (0%) | 0/19 (0%) |
| No CPM Used | — | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| Mean | 36.2 ± 10.7 | 29.5 ± 11.1 | 32.5 ± 11.3 |
| Sex: Female, Male(Participants) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| Female | 18 | 20 | 38 |
| Male | 1 | 3 | 4 |
| Race and Ethnicity Not Collected(Participants) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| United States | 19 | 23 | 42 |
| BMI(kg/m^2) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| Mean | 27.5 ± 7.0 | 25.1 ± 4.6 | 26.2 ± 5.8 |
| Hand Dominance(Participants) | CPM Used | No CPM Used | Total |
|---|---|---|---|
| Right Handed | 11 | 13 | 24 |
| Left Handed | 8 | 10 | 18 |
Plan to share: No
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Ohio State University