Clinical trial NCT05046600: Registry of Arthrex Hand and Wrist Products
Official title: Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: To assess a change in Visual Analogue Scale (VAS) survey
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Secondary outcomes:
measure: To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Other outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH).
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: