Recruiting

Observational Study

Sponsor:

Arthrex, Inc.

Code:

NCT05046600

Conditions

Ulnar/Radial Collateral Ligament Reconstruction

Ligament Repair or Reconstruction

Small Bone Fragments and Arthrodesis

Scapholunate Ligament Reconstruction

Carpal Fusion (Arthrodesis) of the Hand

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Products listed in cohort description

Study Details

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

Study ID

NCT05046600

Start date

Jul 20, 2021

Status verified date

Jun, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subject requires surgery using Arthrex hand and wrist implants included in the registry.
2. Subject is 18 years of age or over.
3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
4. Subject signed informed consent and is willing and able to comply with all registry requirements

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign-body sensitivity or foreign-body reactions.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature -

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Products listed in cohort description

Depending on approved indication per product

Primary outcome measure

  • To assess a change in Visual Analogue Scale (VAS) survey [ Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively ]

Central Contacts and Locations

Central contacts

Justin F Moss, DHSc,CCRP

7705844972justin.moss@arthrex.com

Locations

MORE Foundation

Recruiting

Phoenix, Arizona, United States, 85023

Banner Health

Recruiting

Tuscon, Arizona, United States, 85006

Contacts

Joshua Hustedt, MD

(520) 694-0111marlenymunoz@arizona.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Jennifer Friend

Jennifer.Friend@duke.edu

Principal Investigator:

Tyler Pidgeon, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26501

Contacts

Faviola Aguilar-Burke

304-598-4000fa00016@hsc.wvu.edu

Principal Investigator:

John Taras, MD

More Information

Sponsor

Arthrex, Inc.

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2025-06-26.