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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-years
Awards & highlights
Study Summary
This trial is to test the safety and effectiveness of the H3 TAR Prosthesis.
Who is the study for?
This trial is for adults with ankle arthritis, including osteoarthritis or arthritis from injury or inflammatory disease. Candidates must be suitable for mobile bearing total ankle replacement (TAR) and willing to follow study procedures and visits. Excluded are those with immature skeletons, poor bone quality, certain circulatory issues, high-impact sports activities, metal allergies, significant risk factors as assessed by a physician, severe limb misalignment or deformity, inadequate ligament support that can't be fixed surgically, neuromuscular diseases affecting the ankle function, prior deep infections in the area or previous ankle surgeries like fusion.Check my eligibility
What is being tested?
The Hintermann Series H3 Total Ankle Replacement System is being evaluated post-FDA approval to ensure ongoing safety and effectiveness. This involves collecting data on how well it works in patients who have received this implant as part of their treatment for various types of ankle arthritis.See study design
What are the potential side effects?
While specific side effects aren't listed here due to the nature of the device under study (a prosthetic implant), potential risks may include pain at the site of surgery, infection around the implant, problems with wound healing or skin breakdown overlying the prosthesis and possible need for additional surgeries if complications occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Measurement
Primary Safety Measurement
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.
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Who is running the clinical trial?
DT MedTech, LLCLead Sponsor
Melanie TuznikStudy ChairDT MedTech
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The skin and tissue around my surgery area are in poor condition.My legs have poor blood flow as shown by a Doppler test.My bones are too weak to support a medical device due to severe osteoporosis or similar conditions.You participate in high-intensity sports that involve physical contact or jumping.I have had surgery on my ankle before, either a fusion or a replacement.My foot cannot lay flat due to its shape or alignment.I am currently on immunosuppressive therapy.I have a condition that affects my ankle muscle function.You have a known allergy or intolerance to metal.My knee joint is significantly misaligned.My ankle ligament support is too weak and cannot be fixed with surgery.My bones are still growing.I have nerve damage in my foot that could lead to joint problems.I have had a serious infection in my ankle or nearby bones.I have bone death in my ankle due to lack of blood supply.I have arthritis suitable for total ankle replacement as decided by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for enrollment in this medical trial?
"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical study has been ongoing since February 1st 2022 and was most recently updated on June 10th 2022. A total of 232 patients are needed from 4 different trial sites."
Answered by AI
How many individuals is the research team recruiting for this investigation?
"DT MedTech, LLC will be overseeing the trial from two locations: Duke Orhtopaedics Arringdon in Morrisville, North carolina and Los Angeles Institute of Foot and Ankle Surgery in Mission Hills, California. The study necessitates 232 patients that meet all inclusion criteria to commence operations."
Answered by AI
How many healthcare facilities are currently conducting this research project?
"This study is accessible through four medical sites, such as Duke Orhtopaedics Arringdon in Morrisville, Los Angeles Institute of Foot and Ankle Surgery in Mission Hills, Dept. of Orthopedic Surgery and Rehabilitation from the University of Oklahoma at Oklahoma City, with other locations also available."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
Phoenix Foot and Ankle Institute
Spring Branch Podiatry, PLLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I don't have a primary doctor.
PatientReceived 1 prior treatment
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