Clinical trials: Tibial Fractures
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.
Tibial Fractures
Safety Study of Treatment of Leg Fractures
This study evaluates the safety of the EVOS SMALL Plating system in patients who have a fracture of the tibia requiring surgery.
- Trial name
- EVOS SMALL (NCT03881241)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Smith & Nephew, Inc.
Tibial Fractures
Multiregion BHA in 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
- NCT04056429
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41
chronOS Inject in Proximal Tibial Fractures
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- Trial name
- NCT02056834
- Testing
- chronOS Inject
- Where
- 2 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Synthes GmbH
Tibia Plateau Fractures
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the…
- Trial name
- NCT00409799
- Testing
- I-0401 (a new bone graft substitute)
- Where
- 45 sites in Australia, France and 7 more
- Volunteers
- 208 people
- Sponsor
- Kuros Biosurgery AG
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
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.
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
Tibial Fracture
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures…
- Trial name
- NCT02820363
- Testing
- CERAMENT|G, SOC treatment
- Where
- 31 sites in United States, Germany and 2 more
- Volunteers
- 201 people
- Sponsor
- BONESUPPORT AB
Bone Fracture, Tibia Fracture
Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
- Conditions
- Bone Fracture, Tibia Fracture, Femur Fracture
- Trial name
- NCT07518836
- Testing
- femur or tibia fracture, SurgiFill™
- Where
- 3 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.
Tibial Fractures
ACTiF- Assessment of Closed Tibial Fractures
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing…
- Trial name
- NCT00533377
- Testing
- CP-533, 536, Standard of Care, CP-533,536
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
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.
Fracture Femur, Fracture Tibia
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs.
- Trial name
- CETIULTRA-BONE (NCT07299851)
- Testing
- CFA-based food supplement
- Where
- 6 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Pharmanutra S.p.a.
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
Tibial Fracture, Femoral Fracture
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of the magnesium-titanium hybrid intramedullary nail system compared with the marketed…
- Conditions
- Tibial Fracture, Femoral Fracture, Humeral Fracture
- Trial name
- NCT07569575
- Testing
- Magnesium-Titanium Hybrid Intramedullary Nail System, Commercially Locked Metallic Intramedullary Nail
- Where
- 5 sites in China
- Volunteers
- 160 people
- Sponsor
- HuaMg Perfection Med Tech (Suzhou) Co., Ltd.
Tibial Fractures
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical…
- Trial name
- TrigenMETA (NCT01358292)
- Testing
- Semi-extended Surgical Technique, Standard Surgical Technique
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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.
Fracture Healing, Treatment Duration
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal 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 distal tibia fractures.
- Conditions
- Fracture Healing, Treatment Duration, Distal Tibia Fracture
- Trial name
- NCT07138066
- Testing
- Smart Crutch Tips™, Finite Element Analysis (FEA), Iterative walking
- Where
- 18 sites in Ukraine
- Volunteers
- 30 people
- Sponsor
- Comeback Mobility Inc
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics