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CPM for Broken Bones

N/A

Recruiting

Led By Henry C Sagi, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or greater

Have undergone operative intervention for fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this score will be completed at the one-year post-operative visit.

Awards & highlights

Study Summary

This trial will compare how well two different treatments work for patients with certain types of broken bones.

Who is the study for?

This trial is for adults over 18 who've had surgery to fix a broken pelvis, knee cap, or shinbone. It's not for those with other leg injuries affecting weight-bearing, under 18s, prisoners, or pregnant individuals.Check my eligibility

What is being tested?

The study tests if Continuous Passive Motion (CPM) helps reduce pain and the need for painkillers after surgery for certain bone fractures compared to patients who don't receive CPM during their hospital stay.See study design

What are the potential side effects?

While the document doesn't specify side effects of CPM, they can typically include discomfort, swelling in the treated limb, and sometimes joint stiffness from the device's movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Select...

I have had surgery for a broken bone.

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I have a specific type of bone fracture in my hip, knee, or shin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this score will be completed at the one-year post-operative visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this score will be completed at the one-year post-operative visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this score will be completed at the one-year post-operative visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VAS Pain Score

Secondary outcome measures

SF-12

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CPMExperimental Treatment1 Intervention

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.

Group II: No CPMActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPM

2014

N/A

~50

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,294 Total Patients Enrolled

Henry C Sagi, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

CPM Clinical Trial Eligibility Overview. Trial Name: NCT04389749 — N/A

Broken Bones Research Study Groups: CPM, No CPM

Broken Bones Clinical Trial 2023: CPM Highlights & Side Effects. Trial Name: NCT04389749 — N/A

CPM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04389749 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can partake in this research initiative?

"Affirmative. The details on clinicaltrials.gov reveals that this research project, first published on October 6th 2020 is still actively recruiting participants. 100 subjects will be enrolled from a single medical site."

Answered by AI

Is this scientific experiment currently open to new participants?

"Affirmative. Clinicaltrials.gov data reveals that since its initial posting on October 6th 2020, this clinical trial has been actively recruiting participants; it requires 100 volunteers from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures

H. Claude Sagi, MD 2020. "Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04389749.