Clinical trials: Foot Fusion
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
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, 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
Arthritis, Rheumatoid Arthritis
Wright Foot & Ankle Post-Market Observational Study
WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury
- Trial name
- NCT04118894
- Testing
- Foot and Ankle Devices
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Ankle Arthritis, Arthritis Foot
The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic…
- Trial name
- NCT04831645
- Testing
- DynaNail, Tibiotalocalcaneal Arthrodesis
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- MedShape, Inc
Foot and Ankle Disorders, Ankle Fusion, Osteotomy
Burst Biologics Foot and Ankle Registry
This prospective registry was designed as an observational study to ascertain how commercially available Burst Products are being used by foot and ankle surgeons performing procedures which involve bone grafting, as well as…
- Trial name
- NCT03077256
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Burst Biologics
Bunion, Metatarsophalangeal Fusion
Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
- Conditions
- Bunion, Metatarsophalangeal Fusion, Midfoot Fusion, Hindfoot Fusion
- Trial name
- STRIDE (NCT03954639)
- Testing
- EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride
- Sponsor
- Pacira Pharmaceuticals, Inc
Ankle and Hindfoot Arthrodesis
Long-term Safety and Effectiveness of AUGMENT® Injectable 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® Injectable Bone Graft vs. autologous bone graft.
- Trial name
- NCT03998137
- Testing
- AUGMENT® Injectable Bone Graft, Standard of Care
- Volunteers
- 94 people
- Sponsor
- BioMimetic Therapeutics
Surgery, Foot Deformities
Induce XT™ Bone Graft in Foot and Ankle Fusion
The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft material used in surgeries to fill gaps where bone is missing, such as during foot and…
- Conditions
- Surgery, Foot Deformities, Ankle Arthropathy
- Trial name
- NCT06662266
- Testing
- Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Red Rock Regeneration Inc.
Lower Extremity Surgery, Bunion
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Tibiotalar Arthrodesis, Subtalar Arthrodesis
Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate.
- Conditions
- Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis, Talonavicular Arthrodesis
- Trial name
- TAF (NCT00988338)
- Testing
- Trinity Evolution
- Where
- 10 sites in United States
- Volunteers
- 106 people
- Sponsor
- Orthofix Inc.
Arthritis
A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material.
- Trial name
- NCT01224119
- Testing
- Amplex, Autograft bone
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc