Clinical trials: Ankle Disease
Foot Drop, Stroke
TREAT Foot Drop After Stroke With Ankle Robot
Researchers at the University of Maryland Rehabilitation and Orthopaedic Institute are looking for individuals who have suffered a stroke and have leg and ankle weakness (foot-drop), to participate in a pilot study to examine the…
- Conditions
- Foot Drop, Stroke, Hemiparesis
- Trial name
- TREAT (NCT04137809)
- Testing
- AMBLE
- Where
- United States
- Sponsor
- NextStep Robotics Inc.
Diabetes, Peripheral Arterial Disease
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD).
- Trial name
- NCT02145988
- Testing
- DLBS1033
- Where
- 2 sites in Indonesia
- Volunteers
- 11 people
- Sponsor
- Dexa Medica Group
Rheumatoid Arthritis, Arthritis of Ankle
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
- Conditions
- Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis
- Trial name
- NCT05691868
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 400 people
- Sponsor
- Exactech
Peripheral Artery Disease, Vascular Disease
Adenosine-induced Myocardial Blood Flow in Peripheral Artery Disease Patients
The purpose of the study is to assess the effect of blood flow to the heart when subjects are treated with ticagrelor (Brilinta) or clopidogrel (antiplatelet drugs that stop the blood from clumping together) in patients with…
- Conditions
- Peripheral Artery Disease, Vascular Disease, Arterial Occlusion Disease, Intermittent Claudication
- Trial name
- PAD (NCT02121288)
- Testing
- Ticagrelor, clopidogrel
- Sponsor
- AstraZeneca
Neuropathy (Disorder)
Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment
The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle…
- Trial name
- DEFISTEP (NCT05131399)
- Testing
- Phase A1, Phase B1, Phase A2
- Where
- 8 sites in France
- Volunteers
- 20 people
- Sponsor
- Thuasne
Deep Vein Thrombosis, Post-thrombotic Syndrome
Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention.
- Trial name
- CELEST (NCT01578122)
- Testing
- 25mmHg ECS, 35 mmHg ECS
- Where
- 57 sites in France
- Volunteers
- 350 people
- Sponsor
- Laboratoires Innothera
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
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
Hemiparesis;Poststroke/CVA, Gait, Hemiplegic
Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity…
- Trial name
- MECASPRY (NCT04323943)
- Testing
- Ankle Foot orthosis (AFO)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Thuasne
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
Osteoarthritis, Ankle
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint
This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal® used for the symptomatic relief of osteoarthritis in the ankle joint.
- Trial name
- NCT04640974
- Testing
- Cingal
- Where
- 4 sites in Czechia, Poland
- Volunteers
- 25 people
- Sponsor
- Anika Therapeutics, Inc.
Arthritis Foot, Trauma Injury
Artoss Foot and Ankle Surgery Registry
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone products are being used by surgeons performing foot and ankle surgery which involves bone grafting, as well as…
- Conditions
- Arthritis Foot, Trauma Injury, Deformity; Bone
- Trial name
- ARK (NCT04503759)
- Testing
- NanoBone Bone Graft Substitute
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- Artoss Inc.
Ankle Equinus, Ankle Contracture
Ankle Equinus Contracture Treated With Dynamic Splinting
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.
- Conditions
- Ankle Equinus, Ankle Contracture, Diabetes Mellitus
- Trial name
- NCT01238484
- Testing
- Standard of care, Dynasplint
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Dynasplint Systems, Inc.
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, 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
Joint Replacement, Arthropathy
The restor3d Outcomes Registry
The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic…
- Trial name
- NCT07563803
- Testing
- Patient-Specific Orthopedic Implant
- Where
- United States
- Volunteers
- 2,250 people
- Sponsor
- Restor3D
Arthritis, Rheumatoid
INFINITY™ With ADAPTIS™ Technology Study
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty…
- Trial name
- ITAR2 (NCT04594993)
- Testing
- INFINITY™ with ADAPTIS™ Technology Total Ankle System
- Where
- 13 sites in United States
- Volunteers
- 200 people
- Sponsor
- Stryker Trauma and Extremities
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
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
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.