Clinical trials: Tibia Fracture
Tibial Fracture
Assessment of the Verus Frame in Tibial Intramedullary Nailing
This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during…
- Trial name
- NCT07362121
- Testing
- Verus frame to stabilize tibia
- Where
- Finland
- Volunteers
- 25 people
- Sponsor
- Hemitec Finland Oy
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
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.
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
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.
Osteoporosis, Fracture
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures.
- Conditions
- Osteoporosis, Fracture, Aging
- Trial name
- BUSS03 (NCT01123421)
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Artann Laboratories
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.
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 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
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.
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
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
Fractures
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to…
- Trial name
- NCT00387686
- Testing
- rhBMP-2/CPM
- Where
- 68 sites in United States, Argentina and 16 more
- Volunteers
- 367 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Fracture Healing, Tibial Fractures
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.
- Trial name
- NCT07092579
- Testing
- Smart Crutch Tips™, Finite Element Analysis (FEA), Iterative walking
- Where
- 18 sites in Ukraine
- Volunteers
- 30 people
- Sponsor
- Comeback Mobility Inc
Tibial Fractures
Study Evaluating InductOs in Diaphyseal Tibia Fractures
Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.
- Trial name
- NCT00161616
- Testing
- InductOs
- Where
- 27 sites in Belgium, Finland and 10 more
- Volunteers
- 277 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
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
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.
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