Femoro Acetabular Impingement, Hip Labral Tear, Pain, Postoperative
Conditions
Keywords
continuous passive motion device, HOS-ADL, hip arthroscopy
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.
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.
Interventions
CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* undergoing hip arthroscopy to repair a torn labrum
Exclusion criteria
* pregnancy * revision surgery * bilateral surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Usage | Initial two postoperative weeks | Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| No CPM Used No CPM was administered to these subjects. | 23 |
| Total | 42 |
Baseline characteristics
| Characteristic | No CPM Used | Total | CPM Used |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 11.1 | 32.5 years STANDARD_DEVIATION 11.3 | 36.2 years STANDARD_DEVIATION 10.7 |
| BMI | 25.1 kg/m^2 STANDARD_DEVIATION 4.6 | 26.2 kg/m^2 STANDARD_DEVIATION 5.8 | 27.5 kg/m^2 STANDARD_DEVIATION 7 |
| Hand Dominance Left Handed | 10 Participants | 18 Participants | 8 Participants |
| Hand Dominance Right Handed | 13 Participants | 24 Participants | 11 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 42 participants | 19 participants |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 23 |
| serious Total, serious adverse events | 0 / 19 | 0 / 23 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPM Used | Change in Patient Satisfaction and Functional Outcome | 6 weeks postoperative | 74.6 units on a scale | Standard Deviation 14.8 |
| CPM Used | Change in Patient Satisfaction and Functional Outcome | 6 months postoperative | 81.9 units on a scale | Standard Deviation 16.4 |
| CPM Used | Change in Patient Satisfaction and Functional Outcome | 12 weeks postoperative | 81.1 units on a scale | Standard Deviation 14.6 |
| CPM Used | Change in Patient Satisfaction and Functional Outcome | Improvement | 17.0 units on a scale | Standard Deviation 16 |
| CPM Used | Change in Patient Satisfaction and Functional Outcome | Preoperative | 64.5 units on a scale | Standard Deviation 11.6 |
| No CPM Used | Change in Patient Satisfaction and Functional Outcome | Improvement | 20.2 units on a scale | Standard Deviation 15.3 |
| No CPM Used | Change in Patient Satisfaction and Functional Outcome | Preoperative | 62.7 units on a scale | Standard Deviation 15 |
| No CPM Used | Change in Patient Satisfaction and Functional Outcome | 6 weeks postoperative | 72.8 units on a scale | Standard Deviation 12.5 |
| No CPM Used | Change in Patient Satisfaction and Functional Outcome | 12 weeks postoperative | 81.5 units on a scale | Standard Deviation 11.4 |
| No CPM Used | Change in Patient Satisfaction and Functional Outcome | 6 months postoperative | 82.8 units on a scale | Standard Deviation 12.8 |
Comparison: This analysis considers the baseline HOS-ADL measures.p-value: 0.67t-test, 2 sided
Comparison: This analysis considers the 6 week postoperative HOS-ADL measures.p-value: 0.73t-test, 2 sided
Comparison: This analysis considers the 12 week postoperative HOS-ADL measures.p-value: 0.87t-test, 2 sided
Comparison: This analysis considers the 6 month postoperative HOS-ADL measures.p-value: 0.78t-test, 2 sided
Secondary
Analgesic Usage
Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications
Time frame: Initial two postoperative weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPM Used | Analgesic Usage | 239 morphine equivalent doses | Standard Deviation 269 |
| No CPM Used | Analgesic Usage | 330 morphine equivalent doses | Standard Deviation 227 |
p-value: 0.25t-test, 2 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPM Used | Pain Level | 2.94 units on a scale | Standard Deviation 2 |
| No CPM Used | Pain Level | 4.23 units on a scale | Standard Deviation 2 |
p-value: 0.04t-test, 2 sided