Registry of Arthrex Hand and Wrist Products

NCT05046600 | Recruiting FDA Device

• 1 other identifier: AIRR-0010
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 5

Brief Summary

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products

Conditions

Ulnar/Radial Collateral Ligament Reconstruction; Ligament Repair or Reconstruction; Small Bone Fragments and Arthrodesis; Scapholunate Ligament Reconstruction; Carpal Fusion (Arthrodesis) of the Hand; Digital Tendon Transfers; Carpometacarpal Joint Arthroplasty; Arthrodesis; Digital Tendon Transfer; Distal Radius Fracture Fixation

Outcome Measures

Primary Outcomes (1)

• To assess a change in Visual Analogue Scale (VAS) survey

  Patient reported pain scale 0-10 point scale (0 min,10 max)

  Preoperatively, 3 months, 6 months and 12 months postoperatively

Secondary Outcomes (1)

• To assess a change in Veterans Rand 12-Item Health Survey (VR-12)

  Preoperatively, 3 months, 6 months and 12 months postoperatively

Other Outcomes (1)

• Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH).

  Preoperatively, 3 months, 6 months and 12 months postoperatively

Study Arms (1)

All Products listed in Descriptions

Biocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples KreuLock Screws

Device: Products listed in cohort description

Interventions

Products listed in cohort description DEVICE

Depending on approved indication per product

All Products listed in Descriptions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (5)

MORE Foundation

Phoenix, Arizona, 85023, United States

RECRUITING

Banner Health

Tuscon, Arizona, 85006, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

TERMINATED

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26501, United States

RECRUITING

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Justin F Moss, DHSc,CCRP

CONTACT

7705844972; justin.moss@arthrex.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 16, 2021
• Study Start: July 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)