What side effects are associated with this type of intervention?

Continuous Passive Motion (CPM) is generally well-tolerated but can have side effects such as increased pain, swelling, and discomfort at the site of the injury. Other common treatments for broken bones, such as immobilization with casts or braces, can lead to muscle atrophy, joint stiffness, and skin irritation. Surgical interventions may carry risks of infection, blood clots, and complications related to anesthesia. Physical therapy, while beneficial for recovery, can sometimes cause temporary pain and fatigue.

What prior FDA approvals exist?

The FDA has approved various treatments for broken bones, including the use of bisphosphonates like alendronate to improve bone mineral density and reduce fracture risk. Continuous Passive Motion (CPM) is a mechanical treatment used post-surgery to improve joint range of motion and reduce pain and stiffness, although specific FDA approvals for CPM devices are not detailed. CPM is often used alongside other treatments such as physical therapy and pain management to enhance recovery outcomes.

What other types of research exist?

Promising novel alternatives to Continuous Passive Motion (CPM) for broken bones patients include: 1) Progressive eccentric and isometric strengthening exercises, which have shown effectiveness in physical therapy programs. 2) Adaptive devices such as noninvasive neuromodulation therapy, which has been effective in reducing tremor and could potentially be adapted for pain and stiffness management. 3) Lower extremity resistance training, which improves clinical parameters and may be useful for those unable to participate in traditional walking programs.

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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

Must not have

Injury to either lower extremity that affects the patient's ability to weight bear

Under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a machine called Continuous Passive Motion (CPM) that helps move joints for patients recovering from certain bone surgeries. It aims to see if this machine can reduce pain and improve recovery compared to standard physical therapy alone. Continuous Passive Motion (CPM) has been used in various studies to aid in joint recovery and improve range of motion following surgeries such as total knee arthroplasty.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot put weight on one or both of my legs due to an injury.

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I am younger than 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VAS Pain Score

Secondary study objectives

SF-12

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for broken bones include immobilization, surgical intervention, and physical therapy. Immobilization, using casts or splints, stabilizes the bone to allow natural healing. Surgical intervention, such as open reduction internal fixation, involves the use of metal rods, screws, or plates to hold the bone fragments in place. Continuous Passive Motion (CPM) is a mechanical treatment that moves the joint to improve range of motion and reduce pain and stiffness, which is crucial for preventing complications like joint stiffness and muscle atrophy. These treatments are essential for ensuring proper bone healing, restoring function, and minimizing long-term disability.

Orthopedic manual therapy--an overview. Part I: the extremities.Continuous passive motion in the treatment of knee flexion contractures. A case report.Rehabilitation for distal radial fractures in adults.