Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

NCT04389749 | Recruiting FDA Device

• 1 other identifier: OS19088 IRB 2019-0541
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SF-12

  This score will be completed at the one-year post-operative visit.

Study Arms (2)

CPM

EXPERIMENTAL

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

No CPM

NO INTERVENTION

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

Interventions

CPM DEVICE

CPM-continuous passive motion device.

CPM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Univrsity of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Henry C Sagi, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly A Hasselfeld, MS

CONTACT

513-558-1933; hasselky@uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective comparative cohort study

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 15, 2020
• Study Start: October 6, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)