Clinical trials: Fracture of Lower Limb
Hip Disease, Hip Fractures
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real…
- Trial name
- ESOP2 (NCT04193163)
- Testing
- Hip prosthesis - ESOP 2 cementless femoral stem
- Where
- 7 sites in France
- Volunteers
- 10 people
- Sponsor
- FH ORTHO
Fracture of Lower Limb
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
- Trial name
- NCT01308047
- Testing
- Bupivacaine
- Where
- 2 sites in Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Distal Fibular Fracture, Bimalleolar Fracture
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus…
- Conditions
- Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture
- Trial name
- NCT00864877
- Testing
- biodegradable fixation system (Inion OTPS FreedomPlateTM)
- Where
- United Kingdom
- Sponsor
- Inion Oy
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
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
Fractures, Bone, Nonunion of Fracture
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union…
- Conditions
- Fractures, Bone, Nonunion of Fracture, Fractures, Open, Fractures, Ununited
- Trial name
- NCT04299022
- Testing
- Vivigen Cellular Bone Matrix
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- LifeNet Health
Femoral Neck Fractures
Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
- Trial name
- NCT00757653
- Testing
- Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA, Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA, Hip stem with Interloc Titanium surface + Bonemaster H.A
- Where
- United Kingdom
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
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.
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.
Hip Fracture
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following…
- Trial name
- SHIFT (NCT00787358)
- Testing
- ZT-031
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Zelos Therapeutics
Femoral Fractures, Hip Arthropathy
CoCrMo LOCK Bipolar Femoral Heads FU
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads.
- Trial name
- NCT06885359
- Where
- Slovenia
- Volunteers
- 60 people
- Sponsor
- Limacorporate S.p.a
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
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
Hip Osteoarthritis, Hip Disease
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants…
- Conditions
- Hip Osteoarthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04093739
- Testing
- G7 Freedom Constrained Liners
- Sponsor
- Zimmer Biomet
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Tibial Fractures
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Case series of tibial plateau fractures using Norian Drillable.
- Trial name
- NCT01132508
- Testing
- Norian Drillable Bone Void Filler
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 33 people
- Sponsor
- Synthes GmbH
Osteoarthritis, Hip, Rheumatoid Arthritis
Exception Cementless Hip Stem
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia
- Trial name
- Exception (NCT04349046)
- Testing
- Total hip arthoplasty (THA)
- Where
- 6 sites in Belgium, France
- Volunteers
- 332 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
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics