Arthrodesis, Carpal Fusion (Arthrodesis) of the Hand, Carpometacarpal Joint Arthroplasty, Digital Tendon Transfer, Digital Tendon Transfers, Distal Radius Fracture Fixation, Ligament Repair or Reconstruction, Scapholunate Ligament Reconstruction, Small Bone Fragments and Arthrodesis, Ulnar/Radial Collateral Ligament Reconstruction
Conditions
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 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
Interventions
DEVICEProducts listed in cohort description
Depending on approved indication per product
Sponsors
Arthrex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand Score (QDASH). | 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. |
Countries
United States
Contacts
Primary ContactJustin F Moss, DHSc,CCRP
Outcome results
None listed