Clinical trials: Total Ankle Arthroplasty
Ankle Osteoarthritis
TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing
The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative…
- Trial name
- TAR (NCT04709861)
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Ankle Arthritis
Two Year Follow up of Cadence Total Ankle Replacement
Over the last decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load.
- Trial name
- NCT03866642
- Testing
- Cadence Total Ankle Replacment
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Unity Health Toronto
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
Arthrosis, Ankle Arthritis
Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.
On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use.
- Conditions
- Arthrosis, Ankle Arthritis, Ankle Replacement
- Trial name
- NCT07569848
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Istituto Ortopedico Rizzoli
Ankle Osteoarthritis, Ankle - Recurrent Dislocation
Early MOtion Total Ankle Artroplasty
Evaluate the clinical and radiographic results of patients undergoing total ankle arthroplasty and treated in the post-operative period in a randomized manner with early mobilization of the ankle joint or with cast immobilization…
- Conditions
- Ankle Osteoarthritis, Ankle - Recurrent Dislocation, Cartilage Disease, Ankle Arthropathy
- Trial name
- EMOTAA (NCT06525545)
- Testing
- early mobilizzation of the ankle
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- Istituto Ortopedico Rizzoli
Infections, Ankle Arthritis
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic…
- Trial name
- IOTAA (NCT06384651)
- Testing
- Intraosseous Vancomycin Injection, Intravenous Vancomycin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- The Methodist Hospital Research Institute
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
Ankle Arthritis
Gait Analysis of Ankle Arthroplasty and Arthrodesis
Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint replacement or osteotomies (realignment) of bones.
- Trial name
- NCT00921076
- Testing
- Gait Analysis
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- Unity Health Toronto
Ankle Disease
Efficacy of Negative Pressure Wound Therapy After Total Ankle Arthroplasty
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA).
- Trial name
- PICO-PTC (NCT03886818)
- Testing
- Standard dressings, PICO strategy
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Hospices Civils de Lyon
Ankle Osteoarthritis
Total Ankle Replacement for Ankle Arthritis
The purpose of this study is to prospectively evaluate the functional outcome and patient satisfaction of total ankle replacement for tibio-talar osteoarthritis.
- Trial name
- TAR1600 (NCT01986244)
- Where
- United States
- Volunteers
- 1,043 people
- Sponsor
- Duke University
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, Postoperative Pain
Suzetrigine for Postoperative Pain After Total Ankle Replacement
This study is testing whether adding a non-opioid pain medicine called suzetrigine (Journavx) to the usual combination of pain medicines helps people recover more comfortably after ankle replacement surgery.
- Conditions
- Ankle Osteoarthritis, Postoperative Pain, Acute Pain
- Trial name
- SUZY-TAA (NCT07795827)
- Testing
- Suzetrigine
- Volunteers
- 28 people
- Sponsor
- Soheil Ashkani Esfahani
Ankle Arthritis, Wound Complication
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
Patients who undergo total ankle replacement surgery can sometimes develop problems with wound healing after their operation. These complications may include delayed healing, wound opening, or infection, which can lead to…
- Trial name
- TXA in TAR (NCT07828262)
- Testing
- Transexamic acid, Normal Saline (0.9% NaCl)
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Ottawa Hospital Research Institute
Ankle Osteoarthritis
Total Ankle Replacement Using Guides, Expert Versus Trainee
Patient Specific Instrumentation (PSI) is thought to quicken joint arthroplasty surgery by shortening the operation time and improving alignment.
- Trial name
- TARGET (NCT05729958)
- Testing
- CT scan
- Volunteers
- 20 people
- Sponsor
- Centre for Orthopaedic Research Alkmaar
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
Ankle Osteoarthritis
Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement
This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.
- Trial name
- NCT01504438
- Testing
- Salto-Talaris Total Ankle Replacement, STAR Total Ankle Replacement
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Total Ankle Replacement, Total Ankle Arthroplasty
The UK ADAPTIS Study
An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle.
- Trial name
- UK ADAPTIS (NCT06941558)
- Testing
- INFINITY™ with ADAPTIS™ and EVERLAST™
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Northumbria Healthcare NHS Foundation Trust
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.
Tourniquet Hypertension, Intraoperative Hypertension
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic…
- Conditions
- Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion
- Trial name
- NCT04454203
- Testing
- Mepivacaine, Saline, Perifemoral Injection of Local Anesthetic
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Duke University
Osteoarthritis
Total Ankle Replacement Versus Arthrodesis Trial
The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness…
- Trial name
- TARVA (NCT02128555)
- Testing
- Total Ankle Replacement, Arthrodesis
- Where
- 17 sites in United Kingdom
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- University College, London