Clinical trials: Fracture Leg
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
Ankle Fractures, Knee Fractures
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of…
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Trial name
- NCT07473947
- Testing
- Fracture fixation operation
- Where
- Finland
- Volunteers
- 80 people
- Sponsor
- Inion Oy
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet
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.
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft.
- Trial name
- NCT02879149
- Testing
- AUGMENT® Bone Graft, Standard of Care
- Where
- 26 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- BioMimetic Therapeutics
Total Hip Arthroplasty (THA), Hemiarthroplasty
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing…
- Conditions
- Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip, Femoral Neck Fractures
- Trial name
- NCT07651735
- Testing
- Tipmed™ Primary Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 101 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
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
Hip Fractures, Intertrochanteric Fractures
EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture
This study evaluates the effect of EXPAREL on total opioid consumption through 72 hours following fascia iliaca compartment block (FICB) in subjects undergoing repair of intertrochanteric hip fracture.
- Trial name
- RESTORE (NCT03955458)
- Testing
- EXPAREL, Ropivacaine, Bupivacaine Hydrochloride
- Where
- United States
- Sponsor
- Pacira Pharmaceuticals, Inc
Osteoporosis
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study.
- Trial name
- NCT04511364
- Testing
- Clinical imaging is performed during the 24 and 60 month follow-up visits
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- AgNovos Healthcare, LLC
Osteoarthritis, Hip, Femur Head Necrosis
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions.
- Conditions
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
- Trial name
- NCT02288117
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 240 people
- Sponsor
- Waldemar Link GmbH & Co. KG
Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head
- Trial name
- OR3O (NCT04941729)
- Testing
- OR3O™ - Dual Mobility System, Conventional
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
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.
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, 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.
Hip Disease, Hip Fractures
MDR - M/L Taper With Kinectiv Technology Stems and Necks
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip…
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis
- Trial name
- NCT04027140
- Testing
- M/L Taper with Kinectiv Technology Stems and Necks
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Zimmer Biomet
Degenerative Joint Disease, Femoral Fracture
Prospective Post-market Study Examining the Effectiveness of the EcoFit®
The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.
- Conditions
- Degenerative Joint Disease, Femoral Fracture, Osteoarthritis, Hip, Traumatic Arthritis
- Trial name
- NCT04918680
- Testing
- EcoFit® Total Hip System with implacross® E Polyethylene
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Implantcast North America, LLC
Degenerative Osteoarthritis, Rheumatic Arthritis
CoreHip - Post Market Clinical Follow-Up Study
The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU).
- Conditions
- Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip, Necrosis, Femur Head
- Trial name
- NCT03685110
- Testing
- CoreHip Total Hip Arthroplasty
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 248 people
- Sponsor
- Aesculap AG
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.