Clinical trials: Ankle Disease
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
Spider Veins
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
- Trial name
- NCT02754479
- Testing
- Nd:YAG laser
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Talus, Ankle Arthropathy
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion.
- Trial name
- RECLAIM (NCT05231304)
- Testing
- Total Talus Replacement (TTR), Total Ankle Total Talus Replacement (TATTR), Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Restor3D
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
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
Arthritis
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is…
- Trial name
- NCT02025946
- Where
- 8 sites in Belgium, France and 5 more
- Sponsor
- Integra LifeSciences Services
Avascular Necrosis of the Talus
Patient Specific Talus Spacer Post Approval Study
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
- Trial name
- NCT05364606
- Testing
- Patient Specific Talus Spacer
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Paragon 28
Cerebral Palsy
Development of a Robotic Ankle Assist Device
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and…
- Trial name
- NCT04516343
- Testing
- Robotic Ankle Assist Device (RAAD)
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- BiOMOTUM, Inc.
Defect of Articular Cartilage, Osteochondral Lesion of Talus
DeNovo NT Ankle LDC Study
The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting.
- Conditions
- Defect of Articular Cartilage, Osteochondral Lesion of Talus, Osteochondritis Dissecans
- Trial name
- NCT01347892
- Testing
- DeNovo NT Natural Tissue Graft
- Where
- 8 sites in United States
- Volunteers
- 205 people
- Sponsor
- Zimmer Orthobiologics, Inc.
Primary Arthrosis
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.
- Trial name
- STAR 8 (NCT01288586)
- Testing
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Where
- 5 sites in United States
- Volunteers
- 87 people
- Sponsor
- Stryker Trauma and Extremities
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.
Osteoarthritis
Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function…
- Trial name
- NCT03166410
- Testing
- Cell injection
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Texas Plastic Surgery
Arthritis, Rheumatoid, Post-traumatic Osteoarthritis
UK Infinity, Post-Market Clinical Follow-up Study
Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle…
- Conditions
- Arthritis, Rheumatoid, Post-traumatic Osteoarthritis, Degenerative Arthritis
- Trial name
- NCT03063593
- Where
- 12 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- Stryker Trauma and Extremities
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
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 Sprain, Back Pain
Counterpain PXM Versus Diclofenac Versus Piroxicam
The goal of this clinical trial is to learn if a gel containing Piroxicam plus Counterirritant (warming/cooling ingredients) is as effective and safe as two other common anti-inflammatory gels for treating acute muscle, bone, and…
- Conditions
- Ankle Sprain, Back Pain, Osteoarthritis (OA) of the Knee, Tennis Elbow
- Trial name
- NCT07475663
- Testing
- Piroxicam plus Counterirritant (brand name Counterpain® PXM)., Diclofenac Sodium 10 mg (Brand Name Hotin® DCL), Piroxicam 0.5% (Brand name Pirofel® gel)
- Where
- Indonesia
- Volunteers
- 180 people
- Sponsor
- Taisho Pharmaceutical Indonesia
Peripheral Arterial Disease
Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index
Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index.
- Trial name
- NCT01165437
- Testing
- Blood Pressure Measurement
- Where
- United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Summit Doppler Systems, Inc.
Bursitis, Tendinitis
Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Synovitis
Phase III, multicenter, prospective, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib/betamethasone compared with etoricoxib alone in patients with an…
- Conditions
- Bursitis, Tendinitis, Synovitis
- Trial name
- NCT07328022
- Testing
- Fixed Dose Etoricoxib + Betamethasone, Monotherapy Etoricoxib
- Where
- Mexico
- Volunteers
- 89 people
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.