Clinical trials: Ankle
Degenerative Arthritis, Rheumatoid Arthritis
Zimmer Trabecular Metal Total Ankle PMCF
The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty.
- Conditions
- Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
- Trial name
- NCT02038140
- Testing
- Zimmer Trabecular Metal Total Ankle System
- Where
- 11 sites in United States, Canada and 4 more
- Volunteers
- 120 people
- Sponsor
- Zimmer Biomet
Ankle Sprain
Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch
- Trial name
- NCT01957215
- Testing
- Indomethacin
- Where
- 15 sites in China
- Volunteers
- 270 people
- Sponsor
- GlaxoSmithKline
Sprain, Strain
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
- Trial name
- NCT00351104
- Testing
- Ketoprofen Topical Patch 20%
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Alkemira SA
Foot Drop, Stroke
Ankle Robotics After Stroke
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics…
- Conditions
- Foot Drop, Stroke, Hemiparesis
- Trial name
- NCT04594837
- Testing
- PTR Physical Therapy while wearing Robot group (Phase II), Physical Therapy Only (Phase II), Cross over group for Physical Therapy n Sub-Acute group. (Phase II)
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- NextStep Robotics Inc.
Ankle Sprain
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard…
- Trial name
- NCT01255423
- Testing
- Diclofenac sodium topical gel 1%
- Where
- 9 sites in United States
- Volunteers
- 206 people
- Sponsor
- Novartis
Ankle Injury or Chronic Trauma to the Ankle
CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle
The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®
- Trial name
- NCT06137820
- Testing
- Cetilar® (topical cream)
- Where
- 3 sites in Georgia, Italy
- Volunteers
- 80 people
- Sponsor
- Pharmanutra S.p.a.
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.
Ankle Injuries
5% Topical Ibuprofen (IBU) for Ankle Sprain
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain.
- Trial name
- NCT01945034
- Testing
- Topical IBU twice daily, Topical IBU three times daily
- Where
- 19 sites in United States
- Volunteers
- 304 people
- Sponsor
- Pfizer
Non Union Fracture, Non-Union of Ankle Joint Without Infection
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
The study is aimed to compare the effectiveness of "Histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone and pure shredded…
- Trial name
- NCT04705857
- Testing
- "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- Histograft Co., Ltd.
Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR…
- Conditions
- Osteoarthritis Ankle, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Trial name
- NCT04770870
- Testing
- Hintermann Series H3 Total Ankle Replacement System
- Where
- 11 sites in United States
- Volunteers
- 94 people
- Sponsor
- DT MedTech, LLC
Arthrodesis Surgery Involving the Hindfoot or Ankle
AMPLEX Ankle Fusion and Hindfoot
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
- Trial name
- NCT03028415
- Testing
- AMPLEX, Autogenous Bone Graft (ABG)
- Where
- 36 sites in United States, Canada
- Volunteers
- 56 people
- Sponsor
- Ferring Pharmaceuticals
Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury.
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Acute Pain
- Trial name
- BRIGHT (NCT06854016)
- Testing
- Laser therapy, RICE and physiotherapy/exercise protocol
- Where
- 8 sites in Italy, United Kingdom
- Volunteers
- 108 people
- Sponsor
- DJO UK Ltd
Lateral Ankle Instability
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature. Although success rates are high, the incidence of recurrent instability is well documented.
- Trial name
- NCT04770818
- Testing
- Modified Brostrum procedure with Internal Brace Augmentation, Modified Brostrum procedure
- Where
- 3 sites in United States
- Volunteers
- 154 people
- Sponsor
- Arthrex, Inc.
OSTEOARTHRITIS
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
- Trial name
- NCT00642382
- Testing
- Agilus, Normal saline
- Where
- 19 sites in United States
- Volunteers
- 17 people
- Sponsor
- Cartiva, Inc.
Ankle Osteoarthritis, Post-Traumatic Osteoarthritis of Ankle
Post- Approval Hintermann Series H® Study 1
The H3 TAR device received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) on June 4, 2019, and as a condition of that approval, this study is being conducted to provide long-term safety and effectiveness of the…
- Conditions
- Ankle Osteoarthritis, Post-Traumatic Osteoarthritis of Ankle, Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
- Trial name
- NCT06514196
- Testing
- Hintermann Series H3 Total Ankle Replacement System
- Where
- Switzerland
- Volunteers
- 298 people
- Sponsor
- DT MedTech, LLC
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
Elbow Tendinopathy, Ankle Sprains
Hyaluronic Acid for Soft Tissue Injuries
Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHA™, has demonstrated varying degrees efficacy in patients treated for common musculoskeletal tendinopathies and ligament injuries, such as ankle sprains, lateral elbow…
- Trial name
- SAFE (NCT05278897)
- Testing
- Soft Tissue Adapted Biocompatible Hyaluronic Acid
- Volunteers
- 200 people
- Sponsor
- Global Research Solutions
Amputation, Limb Deficiencies
Assessing the DSR Ankle
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle.
- Trial name
- NCT05955378
- Testing
- DSR Ankle, Predicate Ankle
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Synchro Motion LLC
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.