Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
NCT ID: NCT04389749
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-10-06
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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CPM
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.
CPM
CPM-continuous passive motion device.
No CPM
The control group will have typical care, including working with physical therapy 1 to 3 times a week.
No interventions assigned to this group
Interventions
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CPM
CPM-continuous passive motion device.
Eligibility Criteria
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Inclusion Criteria
* Isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture
* Have undergone operative intervention for fracture
Exclusion Criteria
* Under the age of 18
* Pregnant
* A prisoner
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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H. Claude Sagi, MD
Principal Investigator
Principal Investigators
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Henry C Sagi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Univrsity of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Henry Sagi, MD
Role: backup
Other Identifiers
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OS19088 IRB 2019-0541
Identifier Type: -
Identifier Source: org_study_id
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