An observational study in Orthopedics, sponsored by Stryker Trauma and Extremities. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Stryker Trauma and Extremities · Observational
HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.
The objective of this multicenter study is to collect preoperative, intraoperative, intermediate (approx. 2 years), mid-term (approx. 5 years), and long-term (approx. 10 years) postoperative data, on related clinical complications and clinical outcomes on the Sponsors market-approved hand and wrist Pyrocarbon implants, to demonstrate safety and performance of these implants in a real-world setting.
Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
417 patients will be enrolled (About 50 to 80 per implant type). Prospective patients: screening and surgery should occur after the First site initiation visit.
"Ambispective" patients:
For "ambispective" inclusion: must have undergone a Hand or Wrist arthroplasty with a PyC Hand/Wrist study implant before the date of first site initiation visit,
Exclusion Criteria:
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)
Demonstrate a superior (lower) total QuickDASH average by 24 months postoperatively compared to the predefined Minimal Clinically Important Difference (MCID) upper threshold of 36 points. QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).
Time frame: 24 months
Change from baseline in Patient Satisfaction scores
Single, subjective question measuring patient satisfaction; assessed through 4 levels satisfaction: "Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied".
Time frame: up to 10 years
Safety evaluation
Number of device associated and procedure associated adverse events
Time frame: up to 10 years
Implant Survivorship
Rates of revision surgeries; assessed using the Kaplan-Meyer analysis
Time frame: up to 10 years
Clinical assessment: change from baseline in QuickDash score
QuickDash = Disabilities of the Arm, Shoulder and Hand), self-report questionnaire; 11 items to measure physical function and symptoms; items scored on a 1-5-point scale which is then transformed resulting in a score from 0 (least disability) to 100 (most disability).
Time frame: up to 10 years
Clinical assessment: change from baseline in PRWE score
PRWE = Patient-rated Wrist Evaluation; patient reported outcome developed to assess pain in the wrist joint and functional difficulties in activities of daily living resulting from injuries affecting wrist joint area. 15-item questionnaire made of two subscales (pain and function), resulting in a score from 0 to 100; Less score = better outcome.
Time frame: up to 10 years
Clinical assessment: change from baseline in Strength score
Grip/grasp, tip and key pinch strength will be evaluated using a dynamometer.
Time frame: up to 10 years
Clinical assessment: change from baseline in Mobility score
Evaluation of mobility (movement amplitude and functionality) will be assessed through angle measurement, using a goniometer. Measured movements will be flexion/extension, radial deviation/ulnar deviation, pronation/supination, adduction/abduction, opposition.
Time frame: up to 10 years
Plan to share: No
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Stryker Trauma and Extremities