CPM for Broken Bones

Overseen By Kimberly A Hasselfeld, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Lower extremity injury, pregnant, prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Hospital stay (up to 365 days)

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Continuous Passive Motion (CPM) therapy can reduce pain and the need for painkillers after certain leg surgeries. It focuses on patients who have undergone surgery for fractures in the hip socket, thigh bone, or shin bone. Participants will receive either CPM therapy, which uses a machine to gently move the leg and maintain flexibility, or traditional physical therapy. Suitable candidates have had surgery for isolated fractures in these areas and can bear weight on their legs. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-surgical recovery methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Continuous Passive Motion Therapy is safe for patients with fractures?

Research has shown that continuous passive motion (CPM) is generally safe and well-tolerated. Studies have found that CPM can enhance recovery immediately after surgery. For instance, patients who used CPM for a few days post-surgery experienced quicker short-term recovery compared to those who only underwent physical therapy. No major reports of harmful side effects have emerged from using CPM, indicating it is safe for most people recovering from surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Continuous Passive Motion (CPM) technique for broken bones because it offers a unique approach to rehabilitation. Unlike traditional treatments that rely solely on periodic physical therapy sessions, CPM involves a device that gently and continuously moves the joint while patients are resting, potentially enhancing recovery by promoting circulation and reducing stiffness. This method allows for a more consistent and controlled range of motion, which could lead to faster and more effective healing compared to conventional methods. By integrating CPM with physical therapy, there's hope for improved outcomes and a quicker return to daily activities for patients.

What evidence suggests that continuous passive motion is effective for broken bones?

In this trial, participants will be divided into two groups: one will receive Continuous Passive Motion (CPM) therapy, and the other will not. A previous study showed that CPM led to better results in the first three days after surgery compared to physical therapy alone. Patients used CPM to move their joints, aiding recovery after bone surgeries. Other research suggests CPM might improve short-term recovery for certain bone conditions. However, some studies found no benefits of CPM for knee surgery recovery, indicating its effectiveness may vary by surgery type. Overall, evidence on CPM's benefits is mixed, but it could aid early recovery after specific surgeries. ^{2 3 4 6 7}

Who Is on the Research Team?

Henry C Sagi, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had surgery for a broken bone.

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

Exclusion Criteria

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

You are currently in prison.

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open reduction internal fixation surgery followed by either continuous passive motion (CPM) therapy or standard physical therapy during hospital admission

Hospital stay (up to 365 days)

Daily monitoring during hospital stay

Follow-up

Participants are monitored for functional outcomes and pain management effectiveness post-treatment

1 year

1-year post-operative visit

What Are the Treatments Tested in This Trial?

Interventions

• CPM

Trial Overview 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.

How Is the Trial Designed?

Group I: CPM Experimental Treatment 1 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 CPM Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Published Research Related to This Trial

In a study of 35 patients with chronic osteomyelitis, the combination of negative pressure closed drainage and vancomycin-loaded calcium sulfate with autogenous bone led to successful healing in 32 patients, demonstrating its efficacy in treating this condition.

X-ray examinations showed that the calcium sulfate was absorbed within 4 weeks, new bone formation occurred by 8 weeks, and complete healing of bone defects was observed within 6 months to 2 years, indicating a reliable mechanism of action for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study on negative pressure closed drainage combined with vancomycin loaded calcium sulfate and autogenous bone in the treatment of chronic osteomyelitis]. Li, Q., Song, SF., Zhang, W., et al.[2018]

All new or modified medical devices must undergo safety and performance assessments before clinical use, often requiring a CE mark to indicate compliance with safety standards.

The article highlights existing gaps in the assessment system for medical devices and proposes a comprehensive risk management system to improve the objective evaluation of device safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An essential 'health check' for all medical devices. Spencer, SA., Nicklin, SE., Wickramasinghe, YA., et al.[2019]

In a study involving New Zealand rabbits with osteomyelitis, various antimicrobial therapies were tested, revealing that macroporous calcium phosphate foams (CPF) and intrinsic antimicrobial magnesium phosphate cement (MPC) were more effective in containing the infection compared to other treatments.

A new comprehensive scoring method was developed to evaluate the health state of the infected animals, which successfully identified significant differences between treatments that traditional evaluations could not, highlighting its potential to improve the selection of antimicrobial therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo efficiency of antimicrobial inorganic bone grafts in osteomyelitis treatments. Mestres, G., Fernandez-Yague, MA., Pastorino, D., et al.[2019]

In a study of 123 orthopedic trauma patients using negative pressure wound therapy (NPWT), 10% experienced device malfunctions that caused unrecognized interruptions in treatment, leading to significant complications.

These interruptions resulted in a higher incidence of wound complications, including deep infections and graft loss, with 75% of affected patients requiring unplanned surgeries for wound débridement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients. Collinge, C., Reddix, R.[2011]

In a study of patients undergoing computer-assisted total knee arthroplasty (TKA), the use of continuous passive motion (CPM) did not show significant differences in range of motion, edema, functional ability, or pain compared to a control group that received only physical therapy.

Both groups received physical therapy after discharge, and despite the experimental group using CPM three times daily during hospitalization, there were no statistically significant benefits observed over a 3-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of inpatient continuous passive motion versus no CPM in computer-assisted total knee arthroplasty. Alkire, MR., Swank, ML.[2014]

Healthcare practitioners play a crucial role in identifying and reporting problems related to medical devices, which can prevent serious adverse events and enhance patient safety.

Understanding the reporting mechanisms for device-related issues allows healthcare professionals to effectively communicate problems to the FDA, ensuring timely action to protect patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient care by reporting problems with medical devices. White, GG., Weick-Brady, MD., Goldman, SA., et al.[2005]

A total of 1257 medical device reports (MDRs) related to adverse events in dermatology were identified from the FDA's MAUDE database, highlighting the need for better awareness of device-related injuries.

Common adverse events included blistering, burns, and nerve palsy, primarily associated with radiofrequency devices, diode lasers, and intense pulsed light devices, indicating specific areas where safety improvements are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA MAUDE data on complications with lasers, light sources, and energy-based devices. Tremaine, AM., Avram, MM.[2022]

Negative Pressure Wound Therapy (NPWT) has become increasingly popular for treating complex and large wounds, particularly in orthopedic trauma, by using a vacuum system to promote healing.

NPWT is effective as an adjunct to surgical debridement for open fractures and chronic wounds, and it also supports skin grafts and protects wounds at risk of breakdown, backed by both preclinical and clinical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy - a review of its uses in orthopaedic trauma. Putnis, S., Khan, WS., Wong, JM.[2022]

In a study involving 18 pediatric orthopedic patients, continuous passive motion (CPM) was effectively used to improve hip and knee range of motion after surgery or injury, with most patients experiencing reduced joint pain.

The CPM device was well-tolerated by 16 out of 18 patients and did not interfere with other medical treatments, making it a valuable rehabilitation tool in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of continuous passive motion in pediatric orthopedics. Guidera, KJ., Hontas, R., Ogden, JA.[2004]

In a study of 61 patients recovering from total knee arthroplasty, continuous passive motion (CPM) did not show significant benefits in improving range of motion or reducing hospital stay compared to physical therapy alone for those with single knee replacements.

However, for patients who underwent bilateral knee replacements, there was a trend suggesting that CPM might provide additional benefits, with an average increase in passive range of motion of 20.1 degrees compared to 12.7 degrees in the control group, although this was not statistically significant due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous passive motion in the rehabilitation setting. A retrospective study. Nadler, SF., Malanga, GA., Zimmerman, JR.[2019]

Continuous passive motion (CPM) after total knee arthroplasty has been shown to improve postoperative range of motion and reduce hospital stay length, indicating its efficacy in recovery.

The use of CPM is associated with a low incidence of thrombosis and no negative effects on wound healing, suggesting it is a safe intervention for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous passive motion in the after care of knee joint prostheses]. Küsswetter, W., Sell, S.[2006]

In a study of 80 patients recovering from total knee arthroplasty, the use of continuous passive motion (CPM) combined with active exercises did not significantly improve clinical measurements like active range of motion or Knee Society Score compared to active exercises alone.

However, patients using CPM reported significantly lower pain levels, less joint stiffness, and better functional ability, suggesting that while CPM may not enhance objective recovery metrics, it could improve subjective experiences during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous passive motion on the early recovery outcomes after total knee arthroplasty. Richter, M., Trzeciak, T., Kaczmarek, M.[2022]

In a study of 30 patients with acute and chronic osteomyelitis, negative pressure wound therapy was used alongside other surgical methods, and no relapses were observed during follow-up periods averaging 13.6 months.

The results suggest that negative pressure wound therapy is a simple, effective, and cost-efficient treatment option for managing osteomyelitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of acute and chronic osteomyelitis with negative pressure wound therapy]. Tan, YB., Li, H., Pan, ZJ., et al.[2008]

Medical devices can significantly contribute to adverse events in patients, yet they are often overlooked by healthcare providers when diagnosing issues, especially compared to drug products.

This oversight is particularly critical in pediatric patients, who are more vulnerable to device-related complications due to their smaller size and ongoing development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. Samuels-Reid, J., Lawrence, B., Millin, C., et al.[2012]

The FDA's MedWatch program allows consumers and healthcare professionals to voluntarily report adverse events related to medical devices, which is crucial for identifying issues in home and nonclinical settings.

As the use of medical devices increases outside of clinical environments, active participation in reporting by users and caregivers is essential for the FDA to effectively address and manage device-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. Simone, LK., Brumbaugh, J., Ricketts, C.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787984/

Efficacy and safety of continuous passive motion ... For short-term postoperative recovery, CPM produced better results in the first three days of postoperative recovery compared to physical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04389749

Continuous Passive Motion Following Fixation of Pelvic ... 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 ...

3. withpower.com withpower.com/trial/phase-fractures-bone-9-2020-96192

CPM for Broken Bones This trial is testing a machine called Continuous Passive Motion (CPM) that helps move joints for patients recovering from certain bone surgeries.

4. x10therapy.com x10therapy.com/the-scientific-truth-behind-the-cpm-machine/

The Scientific Truth Behind The CPM Machine We show quotes from recent scientific studies that concluded that the CPM Machine has no positive effect on post-knee surgery recovery.

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-08062-0

Clinical evaluation of usefulness and effectiveness of ... The sitting-type CPM had equivalent efficacy to that of the conventional-type CPM but provided higher satisfaction to patients after TKA.

6. aetna.com aetna.com/cpb/medical/data/1_99/0010.html

Continuous Passive Motion (CPM) Machines Background. Published studies suggest that continuous passive motion (CPM) can improve range of motion (ROM) in those patients undergoing surgical release ...

7. physio-pedia.com physio-pedia.com/Continuous_Passive_Motion_(CPM)

Continuous Passive Motion (CPM) Continuous Passive Motion (CPM) therapy uses machines to move a joint passively and repetitively to a set of number of degrees and movement speed.