Stress Fracture

Musculoskeletal disorders and injuries cause significant disability worldwide, affecting people of all ages and leading to pain, limited mobility, and reduced quality of life. This ongoing open-label, single-arm phase I/IIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries and/or degeneration. The study aims to assess safety and changes in pain over one year after treatment with these stem cells. Participants receive 50 million StromaForte cells locally injected under ultrasound guidance at the injury or degeneration site, combined with or without 100 million cells given intravenously over about 30 minutes. If local injection is not possible, only the systemic intravenous treatment is given. Additional doses may be administered with specified minimum intervals between local and systemic doses. Four subgroups based on connective tissue injury or degeneration type are included. During the study, patients are monitored for adverse events up to one year after treatment. Researchers assess pain levels in each injured or degenerated area, quality of life measures using questionnaires, and changes in pain between treatment subgroups. Follow-up can be face-to-face or remote. This comprehensive evaluation will provide data on safety and patient-reported outcomes following StromaForte administration for musculoskeletal conditions.

Non-combat-related muscle, tendon, and bone injuries are common among military personnel, especially new recruits, affecting readiness and causing significant medical costs. This research investigates how hormonal changes, specifically sex hormones like testosterone and estrogen, influence muscle, tendon, and bone function as well as physical and psychological performance under stress. The study aims to improve military physical training and reduce injuries by understanding these hormonal effects. Participants will be assigned to different groups including a control group maintaining normal habits and a stress exposure group undergoing a 4-week military-style physical training program. Some men and women in the stress group will receive medications to suppress natural hormone production and then receive hormone replacement or a placebo. Treatments include a GnRH agonist injection and topical testosterone gels or estrogen/progesterone patches, with dosing varying by group and sex. Throughout the approximately 8-week study, participants will undergo measurements such as muscle and tendon imaging, body composition analysis, blood tests for hormone and biochemical markers, and physical and mental performance evaluations. Researchers will monitor changes in these outcomes over time to assess the effects of hormone suppression and replacement on musculoskeletal resilience and adaptation to stress.

This research aims to compare two surgical treatments for people aged 18 to 55 years undergoing primary hip arthroscopy due to a focal cartilage defect in the acetabulum. It is a pilot randomized controlled trial assessing the effects of autologous matrix-induced chondrogenesis (AMIC) versus microfracture on hip function, quality of life, pain, cartilage repair, and health utility over two years. The study follows participants for 24 months with scheduled check-ins at 6 weeks, 6 months, 12 months, 18 months, and 24 months after surgery. During surgery, all participants will have unstable cartilage removed and microfracture performed by making small holes in the bone to encourage healing. Those in the AMIC group will also receive a collagen matrix implant placed over the cartilage defect to support tissue repair. This matrix is secured precisely and checked arthroscopically to ensure proper placement. Both treatments are done during the same surgical procedure. Participants will attend follow-up visits at set intervals over two years to assess their hip function using the International Hip Outcome Tool (iHOT-33) and other measures such as pain, cartilage repair via MRI scoring, health status, and any adverse events. Researchers will monitor changes from before surgery to 24 months afterward to evaluate the treatments' effects. The trial is led by McMaster University and includes detailed assessments to understand outcomes and safety.

Researchers are investigating the impact of medications with anticholinergic effects on fracture risk in patients with rheumatoid arthritis (RA), a chronic inflammatory disease. This observational study aims to understand how anticholinergic drug use contributes to anticholinergic load and the risk of fractures using the Fracture Risk Assessment Tool (FRAX). The study includes patients diagnosed with RA according to established criteria and considers the role of corticosteroids and other drugs affecting bone health. Participants will be grouped based on their anticholinergic burden, measured by tools including the Anticholinergic Drug Scale, Anticholinergic Cognitive Burden Scale, and Anticholinergic Risk Scale. Bone mineral density will be assessed using Dual Energy X-ray Absorptiometry (DEXA), and fracture risk will be evaluated with the FRAX tool. Demographic data, systemic diseases, medications, laboratory tests, and bone density measurements will be recorded from patient files. During the study, researchers will collect and analyze data on anticholinergic load and fracture risk factors. Laboratory values such as calcium, phosphorus, thyroid hormones, vitamin D, and liver and kidney function tests will be reviewed. Primary outcomes include assessments of anticholinergic cognitive load and risk scales one week after study start, while fracture risk will be a key secondary outcome. The study is expected to run through 2025 and involves outpatient follow-up and data collection.

Researchers are evaluating whether artificial intelligence (AI) can help doctors detect broken bones, joint effusions, dislocations, and bone lesions more quickly and accurately in emergency room settings. This prospective, randomized, controlled trial compares traditional diagnostic methods to AI-assisted X-ray interpretation. The study also aims to see if AI can save time and reduce healthcare costs while improving clinical workflows in orthopedic emergency care. Participants will be assigned to one of two groups: one using standard physician interpretation of X-rays without AI assistance, and the other using AI tools (Aidoc or Gleamer BoneView) integrated into the hospital's imaging system to highlight potential injuries in real time. Both groups will receive standard X-ray imaging of injured arms or legs. The AI serves as a diagnostic aid, with physicians making final diagnoses. The study includes around 4,800 patients presenting with isolated extremity injuries or joint complaints. During the study, participants will undergo routine X-ray imaging and have their images reviewed with or without AI support depending on group assignment. Researchers will collect baseline demographic and clinical data and assess diagnostic accuracy, time to diagnosis, physician confidence, and cost efficiency. Diagnoses will be independently reviewed by experts to ensure accuracy. The study adheres to ethical guidelines and requires informed consent from participants. Results may inform future use of AI in emergency care settings.

Researchers are conducting a prospective, observational cohort study to create a database of normal biomechanics in healthy athletes. The study focuses on measuring muscle strength, movement patterns, and biomechanics to better understand the risk of musculoskeletal injuries, especially anterior cruciate ligament (ACL) injuries. It aims to link these biomechanical factors with new injuries occurring over a 12-month period after initial testing. Athletes of various ages from middle school to university who participate in organized sports will be involved. The study uses advanced three-dimensional motion capture technology without markers to collect detailed biomechanical data. Participants will complete an injury risk screening as part of athletic camps, which includes muscle strength and movement assessments, as well as providing demographic and sports participation information. Follow-up surveys at six and twelve months will track any new injuries. Participants will be evaluated through biomechanical tests and injury risk screenings, with data collected on muscle strength, movement, and other risk factors like concussion history. The main measurement is the occurrence of new injuries within 12 months. This information will help improve care by providing clinicians with normative data to assess readiness for return to sport and guide treatment and prevention strategies for ACL injuries.

Researchers are evaluating blood flow restriction therapy for patients with lower limb extensor injuries such as quadriceps tendon rupture, patella tendon rupture, and patella fracture. This therapy aims to promote muscle growth and strength by restricting venous outflow using an inflatable cuff, creating a high-intensity environment that may improve rehabilitation. The study is randomized and double-blind to compare this therapy against a placebo treatment. Participants will receive six weeks of physical therapy exercises similar to standard care, but with a pressure cuff placed around the upper thigh of the injured leg. In the experimental group, the cuff pressure will restrict approximately 80% of arterial blood flow, adjusted by a device that monitors and controls pressure. The placebo group will have a cuff with pressure set at 50% less than the effective level. The cuff includes safety features like automatic deflation timers and alarms for under or over pressurization. During the study, participants will have their leg extensor strength and knee function measured at the start and after six weeks. Researchers will track changes in muscle strength and recovery using these assessments. The trial lasts for six weeks of treatment with ongoing monitoring for safety and effectiveness. Participants must be between 18 and 65 years old and intend to receive physical therapy as part of their standard care.

Traumatic injuries are a common reason for emergency department visits, and standard X-rays are the main imaging method used to detect bone fractures. However, with the increasing number of patients, emergency staff face challenges in accurately interpreting these images, leading to a higher risk of missed fractures. Researchers are evaluating the use of artificial intelligence (AI) software called "Boneview" to help emergency physicians detect fractures more accurately during their routine work in a real emergency care setting. In this study, after patients receive an X-ray for suspected bone injury, the senior emergency physician first reviews the images without AI assistance and records their diagnosis and decisions about specialist referrals. Then, the same images are processed by the Boneview AI software, and the physician re-evaluates the images considering the AI analysis, updating their diagnosis and management plan as needed. A radiology intern and a specialized radiologist will also read the X-rays twice—first without AI and then with AI assistance—to compare results. This approach aims to see how AI impacts diagnosis and patient care in the emergency department. Participants will receive no extra imaging beyond their standard X-rays, but their X-rays will be reviewed again with AI support to check for any differences in diagnosis. If there is a disagreement between the initial readings and the specialized radiologist's reading, patients may be contacted for further evaluation. The study will measure the changes in emergency room support decisions made with and without AI over one year, tracking how AI influences patient management and care outcomes during their emergency visit.

Researchers are investigating whether giving Fluoxetine immediately after bodily trauma can help reduce negative psychiatric symptoms like PTSD and depression. This study focuses on adults who have suffered musculoskeletal injuries such as fractures or serious chest and abdominal injuries. The trial aims to see if early use of Fluoxetine can also lessen pain, reduce pain interference, and lower opioid use without altering the standard pain medication regimen. Participants will be randomly assigned to receive either Fluoxetine or a placebo. Those in the Fluoxetine group will take 10 mg daily by mouth for the first 14 days, then 20 mg daily for nine months. The medication will be prescribed during the hospital stay, with the first supply given at discharge and refills provided at follow-up visits at 2 weeks, 3 months, and 6 months. The placebo will look identical to Fluoxetine and be dispensed in the same manner. During the study, participants will complete surveys including the Beck Depression Inventory and report pain scores using PROMIS Pain Interference measures from baseline up to 12 months. The research team will monitor participants for side effects and track opioid use. Follow-up visits will help assess recovery, psychiatric symptoms, pain levels, and medication adherence throughout the year-long study period.

Researchers are investigating the potential benefits and safety of acute Cannabidiol (CBD) treatment for pain relief following long bone fractures. This trial aims to evaluate how two daily doses of CBD, compared to a placebo, affect pain symptoms, inflammation markers, opioid use, quality of life, sleep quality, mood, cognition, and orthopedic function. The study focuses on adults aged 18 to 70 who have suffered fractures of the upper or lower limbs and explores CBD's potential to reduce chronic pain development and reliance on opioids after trauma. Participants will be randomly assigned to receive either a low dose of 25 mg CBD twice daily, a moderate dose of 50 mg CBD twice daily, or a matching placebo twice daily, all taken orally with meals for one month. The trial is triple-blinded and placebo-controlled to ensure unbiased results. This controlled treatment period is followed by assessments at 4 weeks and 3 months to monitor changes in pain, inflammation, opioid use, and other health-related outcomes. Study participants will undergo multiple evaluations including pain intensity ratings using the Visual Analog Scale (VAS), Brief Pain Inventory, and various cognitive and mood assessments. Researchers will also monitor opioid usage, inflammation blood markers, orthopedic function, sleep quality, depression, anxiety, and cognitive function at baseline, 4 weeks, and 3 months. The total study duration for each participant includes one month of treatment plus follow-up assessments up to 3 months, with safety monitoring throughout the trial.