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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPM | Active Comparator | 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. |
|
| No CPM | No Intervention | No CPM was administered to these subjects. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Passive Motion | Device | CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks, 12 weeks, and 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Usage | Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Ryan, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No CPM Used | No CPM was administered to these subjects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks, 12 weeks, and 6 months postoperatively |
|
6 months from operation date
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Munsch | Jameson Crane Sports Medicine Institute | 614-293-3600 | maria.munsch@osumc.edu |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Initial two postoperative weeks |
| BG001 | No CPM Used | No CPM was administered to these subjects. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Hand Dominance | Count of Participants | Participants |
|
| OG001 | No CPM Used | No CPM was administered to these subjects. |
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| Secondary | Analgesic Usage | Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications | Posted | Mean | Standard Deviation | morphine equivalent doses | Initial two postoperative weeks |
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| Secondary | Pain Level | Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels. | Posted | Mean | Standard Deviation | units on a scale | Initial two postoperative weeks |
|
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| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | No CPM Used | No CPM was administered to these subjects. | 0 | 23 | 0 | 23 |
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| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |