CPM for Broken Bones

Overseen by Henry C Sagi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Cincinnati

Disqualifiers: Lower extremity injury, pregnant, prisoner, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Continuous Passive Motion Therapy for broken bones?

Research shows that Continuous Passive Motion (CPM) can help improve joint movement and reduce pain in children after surgery or injury. It has also been found to aid in recovery after knee surgeries by improving joint flexibility and potentially shortening hospital stays. ^{1 2 3 4 5}

Is Continuous Passive Motion (CPM) Therapy safe for humans?

The safety of medical devices, including Continuous Passive Motion (CPM) Therapy, is monitored by the FDA through reports of adverse events. While specific safety data for CPM Therapy isn't detailed, the FDA's system helps identify and address potential safety issues with medical devices in general. ^{6 7 8 9 10}

How does the CPM treatment for broken bones differ from other treatments?

The CPM (Continuous Passive Motion) treatment for broken bones is unique because it involves a machine that gently moves the joint to improve healing and reduce stiffness, unlike traditional treatments that may rely solely on immobilization or physical therapy. This method is particularly beneficial in maintaining joint flexibility and promoting faster recovery. ^{11 12 13 14 15}

Research Team

Henry C Sagi, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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 am 18 years old or older.

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.

I am younger than 18 years old.

You are currently in prison.

Trial Timeline

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

Treatment Details

Interventions

• CPM (Other)

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.

Participant Groups

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+

Dr. Greg Postel

University of Cincinnati

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Dr. Neville G. Pinto

University of Cincinnati

Chief Executive Officer since 2017

PhD in Chemistry from the University of Virginia

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of continuous passive motion in pediatric orthopedics. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Continuous passive motion in the rehabilitation setting. A retrospective study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

[Continuous passive motion in the after care of knee joint prostheses]. [2006]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of continuous passive motion on the early recovery outcomes after total knee arthroplasty. [2022]

6. England pubmed.ncbi.nlm.nih.gov

An essential 'health check' for all medical devices. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Improving patient care by reporting problems with medical devices. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. [2014]

11. United States 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. [2011]

12. Netherlands pubmed.ncbi.nlm.nih.gov

In vivo efficiency of antimicrobial inorganic bone grafts in osteomyelitis treatments. [2019]

13. China pubmed.ncbi.nlm.nih.gov

[Treatment of acute and chronic osteomyelitis with negative pressure wound therapy]. [2008]

14. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy - a review of its uses in orthopaedic trauma. [2022]

15. China 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]. [2018]