Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

University of Cincinnati

Status: Enrolling

Conditions: Fractures, Bone

Treatments: Device: CPM

Study type: Interventional

Funder types: Other

Identifiers

NCT04389749

OS19088 IRB 2019-0541

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CPM

Experimental group

Description:

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.

Treatment:

Device: CPM

No CPM

No Intervention group

Description:

The control group will have typical care, including working with physical therapy 1 to 3 times a week.