Continuous Passive Motion Following Fixation of Pelvic & Knee Fractures

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Fractures, Bone

Clinical Trial Details

NCT number	NCT04389749
Study type	Interventional
Source	University of Cincinnati
Contact	Kimberly A Hasselfeld, MS
Phone	513-558-1933
Email	hasselky@uc.edu
Status	Recruiting
Phase	N/A
Start date	October 6, 2020
Completion date	June 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05555459` - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation	N/A
Completed	`NCT03147222` - Function Focused Care: Fracture Care at Home	N/A
Completed	`NCT03506958` - Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
Completed	`NCT04426981` - Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study	N/A
Recruiting	`NCT05068180` - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients	Phase 4
Recruiting	`NCT05594199` - Feasibility of a Virtual Smoking Cessation Program	N/A
Completed	`NCT04514601` - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Completed	`NCT05138640` - Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
Completed	`NCT02272972` - Performance Improvement Program on Imaging II
Completed	`NCT04215315` - Fracture In Preterm Infants Study (FIPIN Study)
Completed	`NCT03219125` - Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Completed	`NCT04151732` - Factors Associated With Future Fractures in Middle-aged Men and Women
Terminated	`NCT05655130` - Distal Radius Steroid	Phase 1
Completed	`NCT02714257` - Working to Increase Stability Through Exercise	N/A
Completed	`NCT02428244` - Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients	N/A
Recruiting	`NCT04501510` - Ultrasonography in Fracture Management
Completed	`NCT03852095` - Single Time Management Diseases in Pediatric Traumatology
Completed	`NCT04440631` - Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Completed	`NCT03370900` - Learning Retention in Radiograph Interpretation	N/A
Completed	`NCT03819478` - Utilizing Protein During Weight Loss to Impact Physical Function and Bone	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms