Tibial Fractures

13

Review clinical trials related to Tibial Fractures. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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.

Participants needed: 484
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: May 26, 2026Locations: 14
Eligibility criteria

Patients 18 years or older [+1]

Less than 18 years of age [+5]

Status: Recruiting

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.

Participants needed: 100
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: May 14, 2026Locations: 1
Eligibility criteria

Age 18 - 85 years [+1]

Patients not meeting inclusion criteria [+9]

Status: Recruiting

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.

Participants needed: 30
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Comeback Mobility IncUpdated: Apr 14, 2026Locations: 18
Eligibility criteria

Signed informed consent was provided after being fully informed about participat... [+12]

Presence of open or high-energy fractures, multiple lower-limb fractures, or use... [+15]

Status: Recruiting

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.

Participants needed: 497
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Dec 15, 2025Locations: 10
Eligibility criteria

Patients 18 years and older [+1]

Less than 18 years of age [+6]

Status: Recruiting

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.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Zimmer BiometUpdated: Nov 25, 2025Locations: 16
Eligibility criteria

Patient must be 18 or older. [+7]

Patient is unwilling or unable to give consent. [+24]

Status: Recruiting

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.

Participants needed: 40
Trial details
Age: 18-100Biological sex: AllType: InterventionalSponsor: Denver Health and Hospital AuthorityUpdated: Nov 21, 2025Locations: 1
Eligibility criteria

Adult with closed tibial shaft fracture [+1]

History of osteoporosis or osteopenia [+11]

Status: Recruiting

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.

Participants needed: 60
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Major Extremity Trauma Research ConsortiumUpdated: Aug 28, 2025Locations: 4
Eligibility criteria

Between the ages of 18 and 60 years [+4]

Patients not willing to participate [+7]

Status: Recruiting

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.

Participants needed: 1,000
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: Major Extremity Trauma Research ConsortiumUpdated: Jun 5, 2025Locations: 14
Eligibility criteria

All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated... [+2]

Patient unable to provide informed consent [+14]

Status: Recruiting

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.

Participants needed: 98
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Central Finland Hospital DistrictUpdated: Aug 22, 2024Locations: 8
Eligibility criteria

Acute intra-articular proximal tibia fracture with impression of the joint carti... [+3]

Not voluntary [+16]

Status: Recruiting

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.

Participants needed: 130
Trial details
Age: 1-17Biological sex: AllType: ObservationalSponsor: University Hospital, Strasbourg, FranceUpdated: Jul 16, 2024Locations: 1
Eligibility criteria

Minor subject (under 18 years old) [+2]

Presence of opposition from the subject (and/or their legal representative if ap... [+3]

Status: Not yet recruiting

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.

Participants needed: 22
Trial details
Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Patients with bilateral extensive soft tissue damage and poor blood supply. [+1]

Status: Recruiting

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.

Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Umeå UniversityUpdated: Jun 18, 2024Locations: 1Duration: 10 Years
Eligibility criteria

Patients from the region of Norrbotten (northern part of Sweden) who underwent t...

Death without bilateral weighted X-ray minimum 5 years post injury [+6]

Status: Not yet recruiting

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.

Participants needed: 200
Trial details
Age: 10-16Biological sex: AllType: InterventionalSponsor: Foshan Hospital of Traditional Chinese MedicineUpdated: Mar 31, 2016
Eligibility criteria

The fresh fractures, within 7 days [+7]

Old fracture, more than 8 days. [+7]