Overseen ByHenry 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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
+1 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Univrsity of Cincinnati Medical CenterCincinnati, OH
Loading ...
Who Is Running the Clinical Trial?
University of CincinnatiLead Sponsor
References
Use of continuous passive motion in pediatric orthopedics. [2004]Continuous passive motion (CPM) was used to maintain or gain hip and knee range of motion in 18 postoperative or postinjury pediatric orthopedic patients. Continuous passive motion was started in the early postoperative period and augmented with physical therapy. The device was well-tolerated in 16 of the 18 patients. In all but one, motion was improved with a progressive decrease in joint pain. In these patients, CPM was found to be a valuable tool in rehabilitation, and did not interfere with traction, open wounds, nursing care, nor external fixation devices.
Continuous passive motion in the rehabilitation setting. A retrospective study. [2019]Continuous passive motion (CPM) has been commonly used in the postoperative rehabilitation of patients after total knee arthroplasty. In the acute care hospital, most studies have found CPM to be useful in improving range of motion and reducing length of stay. The benefit of CPM in the rehabilitation hospital has not been studied. The charts of 61 patients who had undergone total knee arthroplasty and subsequently were admitted to the East facility of the Kessler Institute for Rehabilitation were reviewed. Patients were separated into two groups: Group 1 received CPM for 3 to 4 hours/day and physical therapy for 2 hours/day. Group 2 received only physical therapy. There was no significant difference in passive range of motion or length of stay between Group 1 and Group 2. An analysis of the 16 patients who underwent bilateral replacement was undertaken. Patients in Group 1 (n = 7) achieved an average increase in passive range of motion of 20.1 degrees, whereas those in Group 2 (n = 9) achieved an increase of 12.7 degrees (P = 0.18). Power analysis demonstrated the need for 50 patients per subgroup to achieve significance. The lack of statistical significance in this subgroup may be a reflection of the small study population (n = 16). The following conclusions can be drawn concerning the use of CPM in the rehabilitation setting: (1) CPM was of no added benefit to those patients admitted after single knee replacement, and (2) CPM may be beneficial to those patients admitted after bilateral knee replacement.
Use of inpatient continuous passive motion versus no CPM in computer-assisted total knee arthroplasty. [2014]Continuous passive motion (CPM) has shown positive effects on tissue healing, edema, hemarthrosis, and joint function (L. Brosseau et al., 2004). CPM has also been shown to increase short-term early flexion and decrease length of stay (LOS) ( L. Brosseau et al., 2004; C. M. Chiarello, C. M. S. Gundersen, & T. O'Halloran, 2004). The benefits of CPM for the population of patients undergoing computer-assisted total knee arthroplasty (TKA) have not been examined.
[Continuous passive motion in the after care of knee joint prostheses]. [2006]Since 1982 there have been many reports on the use of continuous passive motion in the postoperative care of patients with total knee arthroplasty. Continuous passive motion (CPM) has proven to provide good results at our clinic. CPM is often described as having a positive effect on the postoperative range of motion. It also seems to decrease the length of the hospital stay. In addition, a low incidence of thrombosis has been reported and we could detect no negative effects on wound healing.
Effect of continuous passive motion on the early recovery outcomes after total knee arthroplasty. [2022]Continuous passive motion (CPM) is a frequently used method in the early post-operative rehabilitation of patients after knee surgery. In this study, the effectiveness of the CPM method was evaluated after primary total knee arthroplasty during an early recovery period.
An essential 'health check' for all medical devices. [2019]In order to safeguard patient safety, all new or modified medical devices must be assessed for their safety and performance before they are used routinely in clinical practice. Most devices will carry a CE (Confirmity European) mark to demonstrate their safety, but many devices will require an alternative method of assessment. In this article, we discuss the procedures already in place, the significant gaps that exist in the system and the risk management issues. We consider the impact on research and clinical practice, and describe our comprehensive risk management system for objectively assessing the safety of any medical device.
Improving patient care by reporting problems with medical devices. [2005]Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices.
FDA MAUDE data on complications with lasers, light sources, and energy-based devices. [2022]It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues.
Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective. [2012]Medical devices are often overlooked as a contributor to adverse events. In clinical practice, physicians are aware of the potential for adverse effects from drug products, which are routinely included in differential diagnoses of patients' presenting complaints. However, physicians may not always consider that the use, misuse or malfunction of a medical device, and/or its components, may result in a patient's presenting signs and symptoms or lack of improvement. Consideration of medical devices is particularly important in the pediatric population, who may be especially susceptible to device-related adverse events due to their smaller body size, weight and ongoing rapid growth and development.
Medical devices, the FDA, and the home healthcare clinician. [2014]This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments.
The incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients. [2011]Negative pressure wound therapy (NPWT) using the Vacuum Assisted Closure system is an invaluable tool for use on patients with complex limb and soft tissue problems. Recently, the manufacturer (Kinetic Concepts, Inc, San Antonio, TX) made significant modifications to the NPWT platform, including computer software, battery, alarming systems, electric cord and plug apparatus, and others. Since these modifications, we have seen several cases in which the NPWT device has powered off resulting in an unrecognized interruption of therapy. We sought to evaluate the conditions and clinical effects, if any, to orthopaedic trauma patients who experienced an interruption of NPWT therapy when the device powers off.
In vivo efficiency of antimicrobial inorganic bone grafts in osteomyelitis treatments. [2019]The purpose of the present work was to evaluate in vivo different antimicrobial therapies to eradicate osteomyelitis created in the femoral head of New Zealand rabbits. Five phosphate-based cements were evaluated: calcium phosphate cements (CPC) and calcium phosphate foams (CPF), both in their pristine form and loaded with doxycycline hyclate, and an intrinsic antimicrobial magnesium phosphate cement (MPC; not loaded with an antibiotic). The cements were implanted in a bone previously infected with Staphylococcus aureus to discern the effects of the type of antibiotic administration (systemic vs. local), porosity (microporosity, i.e. 5 μm) and type of antimicrobial mechanism (release of antibiotic vs. intrinsic antimicrobial activity) on the improvement of the health state of the infected animals. A new method was developed, with a more comprehensive composite score that integrates 5 parameters of bone infection, 4 parameters of bone structural integrity and 4 parameters of bone regeneration. This method was used to evaluate the health state of the infected animals, both before and after osteomyelitis treatment. The results showed that the composite score allows to discern statistically significant differences between treatments that individual evaluations were not able to identify. Despite none of the therapies completely eradicated the infection, it was observed that macroporous materials (CPF and CPFd, the latter loaded with doxycycline hyclate) and intrinsic antimicrobial MPC allowed a better containment of the osteomyelitis. This study provides novel insights to understand the effect of different antimicrobial therapies in vivo, and a promising comprehensive methodology to evaluate the health state of the animals was developed. We expect that the implementation of such methodology could improve the criteria to select a proper antimicrobial therapy.
[Treatment of acute and chronic osteomyelitis with negative pressure wound therapy]. [2008]To investigate the treatment of acute and chronic osteomyelitis with negative pressure wound therapy.
Negative pressure wound therapy - a review of its uses in orthopaedic trauma. [2022]The use of Negative Pressure Wound Therapy (NPWT) for complex and large wounds has increased in popularity over the past decade. Modern NPWT systems consisting of an open pore foam sponge, adhesive dressing and a vacuum pump producing negative pressure have been used as an adjunct to surgical debridement to treat tissue defects around open fractures and chronic, contaminated wounds. Other uses include supporting skin grafts and protecting wounds at risk of breaking down. This review outlines the current and emerging indications for negative pressure wound therapy in Orthopaedic trauma and the existing preclinical and clinical evidence base for its use.
[Clinical study on negative pressure closed drainage combined with vancomycin loaded calcium sulfate and autogenous bone in the treatment of chronic osteomyelitis]. [2018]To study the clinical effects of negative pressure closed drainage combined with vancomycin loaded calcium sulfate and autogenous bone in the treatment of chronic osteomyelitis.