Registry of Arthrex Hand and Wrist Products
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Products listed in cohort description.
- Who it may be relevant to
- Registry conditions: Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Overview
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Detailed description
The objective of the registry is to evaluate the continued safety and effectiveness of the Arthrex hand and wrist products including the Biocomposite or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction; and/or the DX SwiveLock® SL Anchors (3.5 x 8.5mm) for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, and carpometacarpal joint arthroplasty); and/or, the Headless Compression Screws for small bone fragments; and/or, the arthrodesis Tenodesis Screw (Biocomposite and PEEK), for ulnar collateral ligament reconstruction; and/or, the Corkscrew® Titanium Anchor (Micro Corkscrew® Anchor) for ulnar/radial collateral ligament reconstruction, digital tendon transfers (Nano Corkscrew® Anchor); and/or, the DynaNite® Nitinol Staples for carpal fusion (arthrodesis) of the hand; and/or, the KreuLock™ Screws for Distal Radius
Interventions
- Device Products listed in cohort description
Depending on approved indication per product
Primary outcome measures
- To assess a change in Visual Analogue Scale (VAS) survey [Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively]
Secondary outcome measures (1)
- To assess a change in Veterans Rand 12-Item Health Survey (VR-12) [Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- Subjects that are skeletally immature -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- MORE Foundation — Phoenix
- Banner Health — Tuscon
- University of Iowa — Iowa City
- Duke University — Durham
- West Virginia University — Morgantown
Identifiers
NCT: NCT05046600 · AIRR-0010