Clinical Research Directory

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for tibial shaft fractures. The study will also assess how safe and practical this approach is in daily outpatient use. Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which leads to faster healing, earlier mobility, and better outcomes. Participants will: Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.

Conjoint Analysis of Patient Preferences in Joint Interventions

This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.

Intramedullary Calcium Sulfate Antibiotic Depot

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

Blood Flow Restriction Training in Patients With Lower Extremity Fractures

This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)

The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures. The main questions it aims to answer are: Will intramuscular pressure (IMP) be lower in the TUF cohort compared to controls? Will the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort? Are interstitial fluid biomarkers predictive of ACS? Researchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery. Participants will: Be enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours. Receive continuous anterior compartment pressure monitoring. Undergo standard-of-care clinical evaluation and treatment. (TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid. Return for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes. (Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

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.

Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

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.

Prosthesis Versus Osteosynthesis in Proximal Tibia Fractures

The aim of this study is to compare knee function and pain one year after treatment of intra-articular proximal tibia fracture using either osteosynthesis with a locking plate (ORIF) or primary total knee replacement (TKR) in patients over 65 years of age.

Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents

Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.

Results of Cross-leg Free Vascularized Fibular Graft

This study aims to evaluate the new technique of cross-leg vascularized fibular graft for reconstruction of post-traumatic long tibial bone defects in terms of restoring normal anatomy and function of the traumatized limb in a series of cases admitted in Assiut University hospital, Orthopedics and trauma surgery department.

Knee Osteoarthritis in the Region of Norrbotten

The goal of this observational study is to assess the prevalence of radiographic knee osteoarthritis and to report medium and long term functional outcomes secondary to tibia plateau fractures. The second aim was to investigate whether there were any risk factors associated with these outcomes.

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

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.

Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?

High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.

Study of Prognostic Factors of the Distal Epiphysis of the Tibia Fracture Prognosis

Background: Epiphysis of distal end of tibia fracture is quite common in children epiphysis injury, because of the complex damage mechanism and often leads to growth retardation and joint deformity, the patient's physical and mental damage larger; also epiphysis injury restoration requires higher standard and more difficult to fixed, and methods are being actively explored to improve the curative effect and prevent the sequelae. Our hospital pediatric department of orthopedics expects to conduct prospective study through multi center to study the influence of factors such as the tibia epiphysis fracture of distal injury's mechanism and initial and residual displacement and treatment etc. on patients' prognosis of late growth disorders, joint deformity and ankle function. Methods and analysis: To join the multi center research collaboration group of the south pediatric department of orthopedics (including Pediatric Department of orthopedics of Wuhan Union Hospital, Wuhan Tongji Hospital, Hunan Children's Hospital, Wuhan women and children's Hospital, Foshan Hospital of traditional Chinese medicine, Shenzhen children's Hospital, Guangzhou city women and children's Medical Center), the formation of multi center research network, writing program, including the inclusion and exclusion criteria, grouping and follow-up time, method. Participating in the working group meeting, listening to the expert's opinions to improve research programs, formulate the tracking table of distal tibial epiphyseal fracture, and starting to implement after approved by the medical ethics committee of each hospital. The hospital is responsible for supervision in the whole process of project implementation, and building the real-time reporting system, and it is the responsible person of pediatric department of orthopedics of Foshan Hospital of TCM to do the random inspection. After the completion of data collection, data entry and statistical analysis conducted by the pediatric department of orthopedics in Foshan Hospital of TCM. Ethics and promotion: The research is approved by the hospital medical ethics committee of the south pediatric orthopedics multi center cooperative research group. Single blind method is performed for children in the course of the study. Research data is shared by all participating units and joints promotion of research results. Registration: To register and update the study on the United States NIH ClinicalTrials.gov website.