OrthopedicsHaWPYCNCT04137237
Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
An observational study of Orthopedics, run by Stryker Trauma and Extremities at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedics
- How many people
- 417 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Nov 2019to Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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: * Screening and surgery occurred before the date of the first site initiation visit, * Follow-up visits (at least the last two) must be prospective (i.e: must occur after the date of the first site initiation visit), * Inclusions of consecutive patients, * Minimum available data must be available for each completed visit.
Who may be able to join
- 18 years or older at the time he/she receives the information and signs the informed consent (when applicable as per local regulatory requirements),
- Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee,
- Willing and able to comply with the requirements of the study protocol,
- For prospective inclusion: considered for treatment with one of PyC Hand/Wrist study implants (primary or revision surgery),
- 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,
- Follow-up visits (at least the last two) must be prospective,
- Patient must have complete information available for each completed visit
Who cannot join
- Patient pertaining to one of the categories referred to as "vulnerable population" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as "particularly vulnerable persons" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA),
- Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times),
- Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Caryn Thompson contact
4 sites in 2 countries
France3 sites, 3 recruiting
- Recruiting
Clinique du Parc
Lyon, 69006
Christophe RIZZO, MD
- Recruiting
Espace Médical Vauban
Paris, 75007
Christian COUTURIER, MD
- Recruiting
Institut de la Main Nantes-Atlantique - Pôle Santé-Atlantique
Saint-Herblain, 44800
Philippe BELLEMERE, MD
Switzerland1 site, 1 recruiting
- Recruiting
Orthopedic Surgeon (Dr. med. Dietmar Bignion)
Bern, 3011
BIGNION Dietmar
About this study
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.
Read the detailed description
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.
- Conditions
- Orthopedics
- Keywords
- Hand, Wrist, Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Secondary outcomes (7)
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".
Measured: up to 10 years
Safety evaluation
Number of device associated and procedure associated adverse events
Measured: up to 10 years
Implant Survivorship
Rates of revision surgeries; assessed using the Kaplan-Meyer analysis
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start14 Nov 2019
- Primary completionJan 2029 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137237
- Sponsor's protocol ID
- 1803-W-HAPYC-RM
- Other IDs
- 2019-A00536-51
- Acronym
- HaWPYC
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study
- ClinicalTrials.gov ID
- NCT04137237
- Acronym / sponsor ID
- HaWPYC / 1803-W-HAPYC-RM
- Conditions
- Orthopedics
- Keywords
- Hand, Wrist, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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: * Screening and surgery occurred before the date of the first site initiation visit, * Follow-up visits (at least the last two) must be prospective (i.e: must occur after the date of the first site initiation visit), * Inclusions of consecutive patients, * Minimum available data must be available for each completed visit.
Key inclusion criteria (7 listed)
- 18 years or older at the time he/she receives the information and signs the informed consent (when applicable as per local regulatory requirements),
- Informed on the study and willing to sign an informed consent form approved by Institutional Review Board or Ethics Committee,
- Willing and able to comply with the requirements of the study protocol,
- For prospective inclusion: considered for treatment with one of PyC Hand/Wrist study implants (primary or revision surgery),
- 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,
Key exclusion criteria (3 listed)
- Patient pertaining to one of the categories referred to as "vulnerable population" in the French Law (articles L. 1121-5 to L. 1121-8 of the French Public Health Code), or as "particularly vulnerable persons" in the Swiss Federal Law (Chapter 3, Sections 1 to 4 of CC 810.30 Federal Act on Research involving Human Beings - Human Research Act, HRA),
- Patient unable to comply with the study procedures based on the judgment of the investigator (e.g. cannot comprehend study questions, inability to keep scheduled assessment times),
- Any medical condition that could impact on the study outcomes functional signification at the investigator's discretion (e.g., neuropathy, allergy…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID)
Time frame: 24 months
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).
7 secondary outcomes
Change from baseline in Patient Satisfaction scores
Time frame: up to 10 years
Safety evaluation
Time frame: up to 10 years
Implant Survivorship
Time frame: up to 10 years
Clinical assessment: change from baseline in QuickDash score
Time frame: up to 10 years
Clinical assessment: change from baseline in PRWE score
Time frame: up to 10 years
Clinical assessment: change from baseline in Strength score
Time frame: up to 10 years
Clinical assessment: change from baseline in Mobility score
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caryn Thompson contact
Rebecca Gibson study director
Stryker Trauma
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedics, run by Stryker Trauma and Extremities at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amjad Uneisi (+33638213703, amjad.uneisi@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total QuickDASH average compared to the predefined Minimal Clinically Important Difference (MCID) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.