A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Subject requires surgery using Arthrex hand and wrist implants included in the registry.
Subject is 18 years of age or over.
Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
Subject signed informed consent and is willing and able to comply with all registry requirements
Insufficient quantity or quality of bone.
Blood supply limitations and previous infections, which may retard healing.
Foreign-body sensitivity or foreign-body reactions.
Any active infection or blood supply limitations.
Approximately 50 subjects, male and female, 18 years of age or older will be enrolled for each product and material. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
Cohort
Prospective
Products listed in cohort description
DeviceDepending on approved indication per product
To assess a change in Visual Analogue Scale (VAS) survey
Patient reported pain scale 0-10 point scale (0 min,10 max)
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH).
Self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
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