Registry of Arthrex Hand and Wrist Products

Recruiting

• Conditions: Ligament Repair or Reconstruction; Digital Tendon Transfers; Scapholunate Ligament Reconstruction; Carpal Fusion (Arthrodesis) of the Hand; Ulnar/Radial Collateral Ligament Reconstruction; Small Bone Fragments and Arthrodesis; Carpometacarpal Joint Arthroplasty
• Interventions: Device: Products listed in cohort description

• Registration Number: NCT05046600
• Lead Sponsor: Arthrex, Inc.

Brief Summary

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 include the Biocomposite™ or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction, DX SwiveLock SL (3.5 x 8.5mm) is indicated for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, digital tendon transfers, and carpometacarpal Joint Arthroplasty). Headless Compression Screws for small bone fragments and arthrodesis Tenodesis Screw™ (Biocomposite and PEEK), for ulnar collateral ligament reconstruction,Corkscrew® Titanium for (scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction (Micro Corkscrew), digital tendon transfers (Nano Corkscrew) and DynaNite Nitinol Staples for carpal fusion (arthrodesis) of the hand.

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 study 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Products listed in Descriptions	Products listed in cohort description	Biocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)	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

Trial Locations

Locations (4)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

MORE Foundation; 🇺🇸 Phoenix, Arizona, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States