An interventional study of CPM in Fractures, Bone, sponsored by University of Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Other
The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (CPM) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.
This will be a prospective comparative cohort study analyzing the practices of three surgeons, one of whom routinely uses CPM following fixation of pelvic and acetabular fractures, and two surgeons who do not.
All patients, over the age of 18 years who have undergone open reduction and internal fixation (ORIF) of isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture will be asked to participate. Those who consent will be randomized into two groups. The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week. The control group will have typical care, including working with physical therapy 1 to 3 times a week. The investigators will directly compare the VAS scores and narcotic pain medication requirements in the patients who have CPM versus those who do not during the course of the hospital admission. VAS scores will be assessed throughout the day by RN and/or PT. Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12. Orthopedic Resident or Nurse Clinical will check the patient for incision integrity each day and each session of using the CPM, the patient will be monitored for adverse events. Data will be collected using Epic.
The investigators will record patient demographics including age, sex, and pre-existing narcotic usage. Fracture type according to the Orthopaedic Trauma Association will be recorded. VAS scores and pain medication requirements will be recorded from the first 48 hours during the patient's stay. Pain scores and CPM use will be obtained from Epic using the flowsheet.
Functional outcomes will be assessed at the one-year mark using the Iowa and Majeed pelvic functional outcome tools along with the SF-12.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
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Exclusion Criteria:
The experimental group will have a CPM applied in the PACU immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with Physical Therapy (PT). The experimental group will also have traditional PT, including sessions 1 to 3 times a week.
Device: CPM
The control group will have typical care, including working with physical therapy 1 to 3 times a week.
CPM-continuous passive motion device.
VAS Pain Score
Pain will be assessed by the patient on a scale of 1-10 during hospitalization. 1=no pain; 10=worst pain
Time frame: Visual Analog Score for pain will be recorded daily after the surgery each day until the patient is discharged or up to 365 days..
SF-12
The Short Form 12 (SF-12) uses just 12 questions to measure functional health and well-being from the patient's point of view. An algorithm is used to generate the physical and mental health composite scores for comparison to normative data. The mean score is set to 50. Scores \>50 indicate better physical or mental health than to mean. Scores \<50 indicate worse physical or mental health than the mean.
Time frame: This score will be completed at the one-year post-operative visit.
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2020 (actual). Primary completion is estimated for Jun 2026, 68 months after the start.
Of 148 non-industry interventional studies with no phase under Fractures, Bone, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 68 months is above that.
Counting every sponsor, half of 166 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
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