Clinical trials: Post-Traumatic Osteoarthritis of Ankle
Post-traumatic; Arthrosis, Tibial Fractures
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis.
- Conditions
- Post-traumatic; Arthrosis, Tibial Fractures, Post-Traumatic Osteoarthritis of Ankle
- Trial name
- NCT05652881
- Testing
- Joint Lavage
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- United States Naval Medical Center, San Diego
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
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.
Osteoarthritis
Prevention of Post-Traumatic Osteoarthritis (OA)
Joint injury and trauma dramatically increase the risk of developing osteoarthritis (OA). The purpose of this study is to determine what factors lead to decreased pain, improved joint function, and repair of the joint surface in…
- Trial name
- NCT00054821
- Testing
- Ankle distraction permitting motion, Ankle distraction without motion
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Ned Amendola
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
Ankle Fractures, Post-traumatic Osteoarthritis
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage.
- Conditions
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- Trial name
- PRMRP-FPA2 (NCT04562896)
- Testing
- Custom Carbon Fiber Dynamic Orthosis (CDO)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Iowa
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
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.
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
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
Healthy, Lower Limb Injury
Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that…
- Conditions
- Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
- Trial name
- AFOCUFF (NCT05456295)
- Testing
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Iowa
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.
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 Fractures, Post-traumatic Osteoarthritis
Custom Dynamic Orthoses to Reduce Articular Contact Stress
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle. Research suggests that ankle arthritis develops following ankle fracture due, in part, to elevated forces on the cartilage.
- Conditions
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- Trial name
- PRMRP FPA CT (NCT05209347)
- Testing
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Where
- United States
- Sponsor
- University of Iowa
Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot
Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
The objective of this study is to prospectively evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent double or triple arthrodesis using CCS screws.
- Trial name
- NCT02619838
- Testing
- Aptus CCS 5.0 or/and 7.0 screws
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Duke University
Post-Traumatic Osteoarthritis of Ankle, Ankle Osteoarthritis
Indications for Osteochondral Allograft Transplantation
With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle.
- Conditions
- Post-Traumatic Osteoarthritis of Ankle, Ankle Osteoarthritis, Ankle Injuries
- Trial name
- NCT03711747
- Testing
- Osteochondral allograft ankle
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Missouri-Columbia