Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone
• Intervention / Treatment: Device: CPM

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly A Hasselfeld, MS; Phone Number: 513-558-1933; Email: hasselky@uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • Univrsity of Cincinnati Medical Center
      • Contact: Henry Sagi, MD; Phone Number: 5137776213
      • Contact: Kim Hasselfeld, MS; Phone Number: 5137776213; Email: hasselky@uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CPM; CPM-continuous passive motion device.
No Intervention: No CPM; The control group will have typical care, including working with physical therapy 1 to 3 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Henry C Sagi, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: OS19088 IRB 2019-0541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes