Clinical trials: Total Ankle Replacement
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
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
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 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.
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
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
Arthrodesis, Degenerative Arthritis
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Trial name
- NCT01366989
- Testing
- Radiographic evaluation of previously implanted patients
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Stryker Trauma and Extremities
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.
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
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
- Conditions
- Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
- Trial name
- NCT06311331
- Testing
- Total Talus Replacement (TTR)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Restor3D
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
Rheumatoid Arthritis, Degenerative Arthritis
Clinical Evaluation of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (CADENCE)
A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for…
- Conditions
- Rheumatoid Arthritis, Degenerative Arthritis, Post Traumatic Arthritis
- Trial name
- Cadence (NCT03142958)
- Testing
- Integra Cadence Total Ankle System
- Where
- 11 sites in United States, Canada
- Volunteers
- 132 people
- Sponsor
- Smith & Nephew, Inc.
Arthritis, Rheumatoid
INFINITY™Total Ankle Replacement Follow-up
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects…
- Trial name
- ITAR (NCT03277989)
- Where
- 9 sites in United States
- Volunteers
- 155 people
- Sponsor
- Stryker Trauma and Extremities
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
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
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
Osteoarthritis, Post-Traumatic Arthritis
Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
- Conditions
- Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT00586781
- Testing
- Scandinavian Total Ankle Replacement (STAR)
- Where
- 5 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Link America, 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