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
Foot Surgery, Ankle Surgery
Periarticular Injection Versus Popliteal Block
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
- Trial name
- PvP (NCT04575688)
- Testing
- Exparel, Bupivicaine
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Campbell Clinic
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
Hallux Valgus, Hallux Rigidus
The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
- Trial name
- NCT04473196
- Testing
- weightbearing
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Nova Scotia Health Authority
Vitamin D Deficiency
Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery?
To assess if vitamin D status in the elective foot and ankle fusion population affects fusion healing categorically (fused vs. un-fused).
- Trial name
- NCT04450199
- Testing
- Vitamin D2
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Hallux Valgus
Early Weight Bearing Tarsometatarsal Fusion Study
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight Bearing Following Modified Lapidus Arthrodesis
- Trial name
- NCT03812237
- Testing
- (EWB) Early Weight Bearing (2 Weeks Post-op)
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Orthopaedic Associates of Michigan, PC
Clinical Indication for First Metatarsal Joint Arthrodesis
TMT Fusion Plate vs. Two Crossed Screws
This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment…
- Trial name
- TMT (NCT02096146)
- Testing
- TMT Fusion plate, Two crossed screws
- Where
- 5 sites in United States, Colombia and 1 more
- Volunteers
- 12 people
- Sponsor
- AO Clinical Investigation and Publishing Documentation
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
Bunion, Hallux Rigidus
Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal…
- Trial name
- NCT02499575
- Testing
- 0.5% ropivacaine, Exparel
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OhioHealth
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
Charcot Neuroarthropathy, Diabetic Foot
A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
- Trial name
- NCT01770639
- Testing
- MFB
- Where
- 3 sites in Germany
- Volunteers
- 47 people
- Sponsor
- AO Clinical Investigation and Publishing Documentation
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 Arthrodesis, MTP Arthrodesis
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively.
- Trial name
- NCT04772196
- Testing
- Vitamin D3
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Prisma Health-Midlands
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
Psoriasis
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
- Trial name
- NCT00585650
- Testing
- Etanercept
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Hallux Valgus, Bunion
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.
- Conditions
- Hallux Valgus, Bunion, Patient Spe
- Trial name
- NCT05602844
- Testing
- PSI Lapidus, Conventional Lapidus
- Where
- Hong Kong
- Volunteers
- 54 people
- Sponsor
- Chinese University of Hong Kong