Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

Fractures, Bone Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389749
• Other study ID #: OS19088 IRB 2019-0541
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: Kimberly A Hasselfeld, MS
• Phone: 513-558-1933
• Email: hasselky[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

Device:
• CPM
CPM-continuous passive motion device.

Locations

Country	Name	City	State
United States	Univrsity of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Pain Score	Pain will be assessed by the patient on a scale of 1-10 during hospitalization. 1=no pain; 10=worst pain	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	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.	This score will be completed at the one-year post-operative visit.