Patient AI Trust Dynamics Before and After Orthopedic Consultation (ORTHO-OP-GPT)
NCT07631585
Health Literacy, Orthopedics
Kyrenia, Cyprus
View Trial DetailsNCT Number: NCT04137237
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Clinique du Parc, Lyon, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: up to 10 years
Single, subjective question measuring patient satisfaction; assessed through 4 levels satisfaction: "Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied".
Time frame: up to 10 years
Number of device associated and procedure associated adverse events
Time frame: up to 10 years
Rates of revision surgeries; assessed using the Kaplan-Meyer analysis
Time frame: up to 10 years
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
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
Grip/grasp, tip and key pinch strength will be evaluated using a dynamometer.
Time frame: up to 10 years
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.
Contact information is provided by the study sponsor or research team.
Stryker Trauma and Extremities
Industry
Acronym: HaWPYC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07631585
Health Literacy, Orthopedics
Kyrenia, Cyprus
View Trial DetailsNCT04677907
Orthopedics, Total Knee Replacement
Glasgow, Scotland, United Kingdom
View Trial DetailsNCT05677152
Orthopedics, Traumatology
Vienna, Austria
View Trial DetailsNCT07672158
Blood Loss, Surgical, Brain Damage, Chronic
Melbourne, Victoria, Australia
View Trial Details