Clinical trial NCT04389749: Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Official title: The Role of Continuous Passive Motion in Pain Control of Patients Undergoing Operative Management of Isolated Acetabular Fractures, Supracondylar Femur Fractures, or Tibial Plateau Fracture: a Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective comparative cohort study
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* Isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture
* Have undergone operative intervention for fracture

Exclusion Criteria:

* Injury to either lower extremity that affects the patient's ability to weight bear
* Under the age of 18
* Pregnant
* A prisoner

Primary outcomes:
measure: VAS Pain Score
timeFrame: Visual Analog Score for pain will be recorded daily after the surgery each day until the patient is discharged or up to 365 days..
Secondary outcomes:
measure: SF-12
timeFrame: This score will be completed at the one-year post-operative visit.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Univrsity of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Henry C Sagi, MD
role: PRINCIPAL_INVESTIGATOR
References: