Actively Recruiting
Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Led by Stryker Trauma and Extremities · Updated on 2025-09-16
417
Participants Needed
4
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an international post-market clinical follow-up study to collect safety and performance data on commercially available Pyrocarbon hand and wrist implants. The study aims to gather information on clinical complications and outcomes related to these implants in real-world use, satisfying post-market surveillance and regulatory requirements. This multicenter observational study collects data before surgery, during surgery, and at multiple follow-up points: approximately 2 years, 5 years, and 10 years after the procedure. It focuses on patients treated with sponsor-approved Pyrocarbon implants for hand or wrist arthroplasty, including both primary and revision surgeries. Participants will be assessed using various clinical measurements such as the QuickDASH score, Patient Satisfaction scores, implant survivorship, and safety evaluations over a period up to 10 years. Data collection includes clinical assessments of strength, mobility, and wrist function changes from baseline. This long-term follow-up helps monitor implant performance and participant well-being.
CONDITIONS
Brief Title
Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of informed consent
- Informed about the study and willing to sign an approved consent form
- Willing and able to follow study protocol requirements
- For prospective inclusion: planned treatment with a Pyrocarbon Hand/Wrist implant for primary or revision surgery
- For ambispective inclusion: prior hand or wrist arthroplasty with a Pyrocarbon implant before site initiation
- Follow-up visits must be prospective for at least the last two visits
- Complete information must be available for each completed visit
You will not qualify if you...
- Individuals considered vulnerable populations under French or Swiss law
- Unable to comply with study procedures as judged by the investigator
- Any medical condition that could affect study outcomes, such as neuropathy or allergies, at investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Short-term prior to surgery
Participants undergo preoperative assessments before receiving the Pyrocarbon implant surgery.
Duration - Surgery day and immediate recovery period
Participants receive the Pyrocarbon hand or wrist implant surgery and immediate post-operative care.
Duration - Up to 10 years
Participants attend follow-up visits to collect clinical outcomes and monitor for complications at intermediate (approx. 2 years), mid-term (approx. 5 years), and long-term (approx. 10 years) intervals.
Follow-up visits at approximately 2 years, 5 years, and 10 years
Trial Site Locations
Total: 4 locations
1
Clinique du Parc
Lyon, France, 69006
Actively Recruiting
2
Espace Médical Vauban
Paris, France, 75007
Actively Recruiting
3
Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique
Saint-Herblain, France, 44800
Actively Recruiting
4
Orthopedic Surgeon (Dr. med. Dietmar Bignion)
Bern, Switzerland, 3011
Actively Recruiting
Research Team
A
Amjad Uneisi
C
Caryn Thompson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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