Clinical trials: Ankle Arthritis
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
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
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
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
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
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
Arthritis Ankle, Arthritis Knee
Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
This clinical study will evaluate the efficacy and safety of intra-articular (IA) recombinant human growth hormone (rhGH; somatropin) combined with platelet-rich plasma (PRP) in adults with treatment-resistant knee and ankle…
- Trial name
- NCT06907121
- Testing
- Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
- Where
- Australia
- Volunteers
- 192 people
- Sponsor
- Integrant Pty Ltd
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
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 sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
- Trial name
- NCT04784273
- Testing
- Tibiotalocalcaneal Arthrodesis, DynaNail
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- MedShape, Inc
Osteoarthritis
ARTEBONE Bone Void Filler in Arthrodesis Procedure of the Ankle
The purpose of this investigation is to assess safety and performance of ARTEBONE Bone Void Filler in the single arthrodesis procedure.
- Trial name
- NCT02480868
- Testing
- ARTEBONE
- Where
- 5 sites in Finland, Poland
- Volunteers
- 34 people
- Sponsor
- BBS-Bioactive Bone Substitutes Oy
Ankle Rheumatoid Arthritis, Arthritis of Ankle
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.
- Conditions
- Ankle Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis
- Trial name
- NCT05619588
- Where
- 2 sites in United States
- Volunteers
- 370 people
- Sponsor
- Exactech
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
Degenerative Arthritis, Rheumatoid Arthritis
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
This study will evaluate the long term performance and safety data for the Cadence™ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g.
- Conditions
- Degenerative Arthritis, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT03247023
- Testing
- Implantation of Integra Cadence Total Ankle System
- Where
- 6 sites in Belgium, Canada and 3 more
- Volunteers
- 65 people
- Sponsor
- Smith & Nephew, Inc.
Post Traumatic Arthritis, Osteoarthritis
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period.
- Conditions
- Post Traumatic Arthritis, Osteoarthritis, Total Ankle Replacement, Total Ankle Prosthesis
- Trial name
- NCT07118501
- Testing
- Total Ankle Replacement
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Stryker Trauma and Extremities
Arthritis, Infection of Total Ankle Joint Prosthesis
INBONE™ Total Ankle Prosthesis With Long Talar Stem
The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.
- Trial name
- NCT01641848
- Testing
- INBONE™ Total Ankle Prosthesis with Long Talar Stem
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stryker Trauma and Extremities
Primary Arthrosis, Post Traumatic Arthritis
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
- Conditions
- Primary Arthrosis, Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
- Trial name
- STAR 2 PAS (NCT01284283)
- Testing
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Encore Medical, L.P.