Clinical trials: Total Ankle Replacement, active
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
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
Ankle Osteoarthritis
Comparison of Customized and Standard Total Ankle Prostheses
The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic…
- Trial name
- NCT06193057
- Testing
- Total ankle arthroplasty
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Istituto Ortopedico Rizzoli
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
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
PROMs, Total Ankle Replacement
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years.
- Conditions
- PROMs, Total Ankle Replacement, Italian Forgotten Joint Score
- Trial name
- NCT06091397
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Istituto Ortopedico Rizzoli
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
Orthopedic Disorder
Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)
Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis.
- Trial name
- ProtesiTT (NCT07168330)
- Testing
- Ankle replacement
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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
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
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
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
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 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
Total Ankle Arthroplasty Surviviorship
Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up
Ankle osteoarthritis is a disabling condition that can significantly impair patients' quality of life. Ankle arthrodesis has historically represented the gold standard for treating this condition [2], but technological…
- Trial name
- ZTM10 (NCT07732153)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Total Knee Replacement, Knee Osteoarthritis
Circulatory Exercise After Total Knee Replacement
Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to…
- Conditions
- Total Knee Replacement, Knee Osteoarthritis, Postoperative Edema, Postoperative Inflammation
- Trial name
- NCT07688642
- Testing
- standard postoperative TKR rehabilitation, Standard Rehabilitation Plus Circulatory Exercise
- Volunteers
- 68 people
- Sponsor
- Assiut University
Ankle Arthrodesis, MTP Arthrodesis
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Vitamin D is important for bone health and recent research has emphasized the importance of adequate vitamin D levels for bone healing, wound healing, and possibly preventing infections post-operatively.
- Trial name
- NCT04772196
- Testing
- Vitamin D3
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Prisma Health-Midlands
Ankle Arthritis
Total Ankle Replacement: Clinical and Radiological Outcomes
This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and…
- Trial name
- NCT03650010
- Testing
- Total ankle replacement
- Where
- Italy
- Volunteers
- 1,066 people, healthy volunteers welcome
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Total Ankle Arthroplasty, Postsurgical Analgesia
Efficacy of EXPAREL vs. Bupivacaine
The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following…
- Trial name
- NCT07212114
- Testing
- EXPAREL, 0.25% bupivacaine (HCl): 50 ml, 0.25% bupivacaine (HCl): 30 ml
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Emory University
Articulation Disorders
Correlation Between Deficits in Knee ROM Recovery and Difficulty in Dorsiflexing the Tibio-tarsal Joint in Patients Undergoing Total Knee Replacement Surgery.
To demonstrate that the deficit in dorsiflexion-tibia-talar joint range of motion can have an effect on the knee operated by arthroplasty by limiting full extension and, in general, the recovery of a full range of motion.
- Trial name
- NODORSIFLEX (NCT07016243)
- Where
- Italy
- Volunteers
- 197 people
- Sponsor
- Istituto Ortopedico Rizzoli