145 Clinical Trials for Bone Fractures
The goal of this clinical trial is to compare casts with cast art versus those without art in children who sustain a fracture of the extremity. The main goals are: * Determine the difference in satisfaction as measured by the visual analog scale for satisfaction between patients treated in a cast with cast customization versus those in a cast with no cast art * Determine the difference in perceived pain scores between patients treated in a cast with cast customization versus those in a case with no cast art Participants will be randomized to one of three groups: one with plain white cast, one with cast of color wrap of choice, and one with custom cast art. Researchers will compare to see the differences in satisfaction and perception of pain based on what cast the study participant receives.
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are: Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels? Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
The purpose of this study is to determine whether an indocyanine green (ICG) fluorescence imaging system (cBPI) can be used to provide surgeons with information about bone health or bone blood flow. This will help surgeons better understand the healing potential of bone and relative risk of complication. This is important to help surgeons select the most appropriate treatment for severe traumatic injuries and infections.
An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.
The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.
Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health
The aim of this project is to assess the effectiveness of the IlluminOss pelvic implants in patients with pelvic metastatic disease presenting with pain, risk of pathologic fracture, non-displaced or minimally displaced pathologic fracture of the pelvis, and geriatric patients with pelvic fragility fractures. Results from this study will be used to confirm preliminary clinically and possibly statistically significant reductions in pain and improvements in function among these patients.
The investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (CPM) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.
Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.
Addictive full-agonist opioids, like oxycodone and hydrocodone, are often used to treat pain after surgery. However, these full-agonist opioids can be very addictive. After ankle fracture surgery, about 1 in 5 patients that did not take opioids before surgery become addicted to opioids after surgery. Buprenorphine is an opioid with unique properties that may offer a way to reduce the number of patients that become addicted to opioids after surgery. Buprenorphine has good analgesic (painkilling) effects. It is also thought to be less addictive and cause less of a high than full-agonist opioids, like oxycodone and hydrocodone. This project's goal is to determine if transdermal buprenorphine can safely and effectively control pain after ankle fracture surgery. This study will be a pilot study, which sets the stage for future studies that investigate whether buprenorphine can reduce the rate that patients become addicted to opioids after surgery. This study's multidisciplinary team will divide patients into two groups. Participants in one group will be treated with a 7-day transdermal buprenorphine patch (where the buprenorphine is slowly absorbed through the skin over 7 days). Participants in the other group will be treated with a placebo patch. A placebo has no drug in it, it just looks like the buprenorphine patch. Aside from the buprenorphine patch or placebo patch, both groups' pain management plans will be the same as if they were not in the study. Over the first week after surgery, the investigators will measure the amount of full-agonist opioids (for example, oxycodone or hydrocodone) that participants consume, participants' pain scores, the frequency of side effects related to opioids, and the number of calls and patient portal messages to the clinic for uncontrolled pain. The investigators will also assess whether participants are continuing to use opioids 3 months after surgery for pain related to their ankle fracture.
Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.
This study is a randomized controlled trial comparing outcomes between geriatric hip fractures who received a commercially available (XR RecoveryTM, Salt Lake City Utah) peri-operative nutritional supplement for three weeks post-operatively to those who receive standard nutritional counseling. The main question it aims to answer is: - Does supplementation decrease muscle loss via ultrasound measurements of the cross-sectional area of the rectus femoris of the uninjured leg?
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.
This study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). Patients will be randomly assigned to one of the following three groups: 1) ESP block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids. Our specific aims are: 1. To compare the opioid use and pain ratings over the first 72 hours after enrollment. 2. To quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention. 3. To explore the impact of ESP blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory). Inclusion Criteria: • Adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital. Exclusion Criteria: * Allergy to amide local anesthetics, lidocaine, or ropivacaine * Pregnancy * Bilateral rib fractures * Coagulopathy (INR \> 1.5; PTT \> 1.5 times ULN, or platelets \< 75,000) * Conduction block on EKG * Total body weight \< 40 kg * Painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen * Spine fracture at the level of intended ESP block * Infection near the ESP insertion site or active bacteremia or sepsis * Any patient deemed a poor candidate for ESP block and/or lidocaine infusion will also be excluded
The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \<10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.
RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.
The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 27 months.
The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.
This application addresses the Peer Reviewed Medical Research Program Investigator-Initiated Research Award FY21 W81XWH-22-CPMRP-IIRA area of Chronic Pain Management Research Program- The investigators will utilize subjects who have sustained ankle fractures and may develop chronic pain following bone union. No attempt will be made to affect the experimental outcome in the subjects. This study will adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research.
The hypothesis of this study is that the Rim Plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.
The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter.
This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome.
The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.
The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are: * Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. * Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours. Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.
Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.