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NCT Number: NCT05046600

Registry of Arthrex Hand and Wrist Products

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

Recruiting

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Products listed in cohort description

Device

Depending on approved indication per product

Primary outcomes

  1. 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)

Secondary outcomes

  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

    Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin F Moss, DHSc,CCRP

CONTACT

[email protected]

7705844972

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2021
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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