Clinical trials: Fracture Tibia
Tibial Fractures
Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
The purpose of this study is to determine the effect of low-intensity, pulsed ultrasound on tibial fractures treated with intramedullary nailing.
- Trial name
- TRUST (NCT00667849)
- Testing
- Exogen 4000+
- Where
- 16 sites in United States, Canada
- Volunteers
- 501 people
- Sponsor
- Bioventus LLC
Congenital Pseudarthrosis of Tibia
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft…
- Trial name
- NCT07112443
- Testing
- NVD003, Iliac Crest Bone Graft
- Where
- 7 sites in United States, Belgium and 2 more
- Volunteers
- 12 people
- Sponsor
- Novadip Biosciences
Osteoarthritis, Knee, Rheumatoid Arthritis
A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System
A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.
- Conditions
- Osteoarthritis, Knee, Rheumatoid Arthritis, Post-Traumatic Osteoarthritis of Knee, Varus Deformity, Not Elsewhere Classified, Knee
- Trial name
- NCT03511144
- Testing
- Unity Knee™ TKR using measured resection, Unity Knee™ TKR using ligament balancing
- Sponsor
- Corin
Surgical Wound Infection
Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
- Trial name
- NCT04906642
- Testing
- Next Science, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Next Science TM
Congenital Pseudarthrosis of Tibia
NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia
A single arm, multi-country, multi-center study in pediatric patients, suffering from congenital pseudarthrosis of the tibia (CPT), treated during the primary surgical intervention with NVD-003, an autologous 3D scaffold free…
- Trial name
- NCT05693558
- Testing
- NVD-003, an autologous 3D scaffold free osteogenic graft
- Where
- 2 sites in United States, Belgium
- Volunteers
- 4 people
- Sponsor
- Novadip Biosciences
Tibial Fractures
Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT03826784
- Testing
- BHA
- Where
- United States
- Sponsor
- Carmell Therapeutics Corporation
Wrist Injury, Tibial Fracture
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Trial name
- TOMO (NCT01927575)
- Testing
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fujifilm Medical Systems USA, Inc.
Tibia Fracture Non Union Bone
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a…
- Trial name
- NCT00726193
- Testing
- OsteoGen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Zimmer Biomet
Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture
Observational Patient Registry of the Dynamic Locking Screws
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.
- Conditions
- Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture, Diaphyseal, Distal or Proximal Tibia Fracture
- Trial name
- DLS (NCT02656628)
- Testing
- Dynamic Locking Screw 3.7mm and 5.0mm
- Where
- Australia
- Sponsor
- Synthes GmbH
Femoral Fractures, Tibial Fractures
Depuy Synthes Lower Extremity Shaft Nail Registry
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA)…
- Trial name
- NCT05272631
- Testing
- Retrograde Femoral Nail Advanced, Tibial Nail Advanced
- Where
- 8 sites in United States
- Volunteers
- 241 people
- Sponsor
- DePuy Synthes Products, Inc.
Tibia Fractures
Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures
This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D…
- Trial name
- NCT01282294
- Testing
- ETN PROtect
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Synthes GmbH
Tibial Fractures, Open Fractures
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study.
- Trial name
- NCT02491047
- Testing
- BonyPid-1000, Standard of Care (SOC) treatment
- Where
- 9 sites in Israel, Philippines
- Volunteers
- 51 people
- Sponsor
- PolyPid Ltd.
Tibia Fracture
OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting
A prospective, randomized, evaluator-blinded, controlled study for subjects with open tibial fractures classified as Gustilo type II, IIIA or IIIB (see Appendix 1) who will receive bone graft implantation for the potential of…
- Trial name
- NCT04960722
- Testing
- OIF/β-TCP
- Where
- Taiwan
- Volunteers
- 35 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Treatment Duration, Fracture Healing
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia 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 extra-articular proximal tibia fractures.
- Conditions
- Treatment Duration, Fracture Healing, Extra-articular Proximal Tibia Fractures
- Trial name
- NCT07134257
- Testing
- Smart Crutch Tips™, Finite Element Analysis (FEA), Iterative walking
- Where
- 18 sites in Ukraine
- Volunteers
- 30 people
- Sponsor
- Comeback Mobility Inc
Orthopedic Disorder, Trauma Injury
X-BS Ortho Bone Graft Study
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
- Conditions
- Orthopedic Disorder, Trauma Injury, Extremity Injury
- Trial name
- NCT06326827
- Testing
- FDBS (GraftR3®), IBS (MBCP® Putty)
- Volunteers
- 200 people
- Sponsor
- Advanced Medical Solutions Ltd.
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Trauma
Adjunctive Therapy to Treat Tibial Shaft Fractures
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups…
- Trial name
- TSF (NCT00533793)
- Testing
- open fracture reduction
- Where
- 49 sites in Bulgaria, Czechia and 10 more
- Volunteers
- 201 people
- Sponsor
- Kuros Biosurgery AG
Femoral Fracture, Tibial Fracture
The Development of a Surgical Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT01300520
- Testing
- Target Tape
- Where
- Canada
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Aeos Biomedical Inc.
Tibial Plateau Fracture
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture).
- Trial name
- NCT07897149
- Testing
- Crutch Tip Biofeedback System, Individualized FEA-Guided Postoperative Weight-Bearing, Usual-Care Postoperative Weight-Bearing
- Volunteers
- 86 people
- Sponsor
- Comeback Mobility Inc
Tibial Fracture
Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the…
- Trial name
- ALLOB-TF2 (NCT04432389)
- Testing
- ALLOB
- Where
- 39 sites in Belgium, Czechia and 5 more
- Volunteers
- 178 people
- Sponsor
- Bone Therapeutics S.A