Clinical trials: Foot & Ankle
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.
Sensorimotor Gait Disorder, Neurologic Ambulation Disorder
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.
- Conditions
- Sensorimotor Gait Disorder, Neurologic Ambulation Disorder, Gait, Drop Foot, Poststroke Hemiparesis
- Trial name
- L300 (NCT01138995)
- Testing
- Ness L300, Ankle-foot orthosis
- Where
- 11 sites in United States
- Volunteers
- 197 people
- Sponsor
- Bioness Inc
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
Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs
Safety and Performance of PEEK Anchors in Extremities
Safety and performance of the study devices in extremities up to 12 months post-surgery
- Conditions
- Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- NCT03782298
- Testing
- Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
- Where
- 4 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
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
Osteoarthritis, Osteo Arthritis Knee
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to…
- Conditions
- Osteoarthritis, Osteo Arthritis Knee, Osteo Arthritis Shoulders, Osteoarthritis of Multiple Joints
- Trial name
- GARM-MSK-ALD (NCT04238143)
- Testing
- Tissue Stromal Vascular Fraction (tSVF) Arm 1, PRP Concentrate Arm 1, Tissue Stromal Vascular Fraction (tSVF) Arm 2
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Healeon Medical Inc
Amputation
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
- Trial name
- NCT02864693
- Testing
- Kinnex, Pacifica LP
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ability Prosthetics and Orthotics, Inc.
Foot Deformities
Bone Healing Accelerant (BHA) Versus Autologous Bone Grafting (ABG) for Hindfoot or Ankle Arthrodesis
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle…
- Trial name
- NCT06258499
- Testing
- BHA
- Sponsor
- Carmell Therapeutics Corporation
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
Stroke
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily…
- Trial name
- NCT01087957
- Testing
- WalkAide, Ankle-Foot Orthosis (AFO)
- Where
- 29 sites in United States
- Volunteers
- 495 people
- Sponsor
- Innovative Neurotronics
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Peripheral neuropathy is a disorder caused by damage to the peripheral nerves. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain chemotherapy drugs, such as platinum-based compounds, taxanes…
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Peripheral Neuropathic Pain
- Trial name
- NCT07072468
- Testing
- VMD-3866 Gel
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- VM Therapeutics LLC
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 Rigidus, Hallux Limitus
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great…
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis
- Trial name
- NCT01284985
- Where
- 4 sites in Czechia, Netherlands and 2 more
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Services
Tendinopathy, Tendon Tear
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
- Conditions
- Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
- Trial name
- NCT03307499
- Testing
- NeoPatch
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- CryoLife, 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
Ankle Arthritis, Foot Arthritis
The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
- Trial name
- NCT03686241
- Testing
- Tibiotalocalcaneal (TTC) arthrodesis, DynaNail
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- MedShape, 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 Deformities, Acquired, Disorder of Joint of Foot
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
- Conditions
- Foot Deformities, Acquired, Disorder of Joint of Foot, Fracture of Foot, Deformity of Bone
- Trial name
- NCT02161016
- Testing
- map3
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- RTI Surgical
Hypertension
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.
- Trial name
- NCT00789321
- Testing
- Comparator: amlodipine besylate
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC