Registry of Arthrex Hand and Wrist Products

June 23, 2025 updated by: Arthrex, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Recruiting
        • MoRe Foundation
        • Contact:
          • Damon Adamany, MD
      • Tuscon, Arizona, United States, 85006
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Terminated
        • University of Iowa
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Tyler Pidgeon, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • John Taras, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Depending on approved indication per product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess a change in Visual Analogue Scale (VAS) survey
Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)
Preoperatively, 3 months, 6 months and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
Preoperatively, 3 months, 6 months and 12 months postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH).
Time Frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Preoperatively, 3 months, 6 months and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRR-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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