Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Conditions

• Akin Osteotomy
• Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus
• First Metatarsophalangeal Arthrodesis
• Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle
• Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)
• Fixation of Small Bone Fragments of the Foot/Ankle
• Hyperpronated Foot
• Lisfranc Arthrodesis
• Medial Ankle Stabilization
• Midfoot and Hindfoot Arthrodeses or Osteotomies
• Mono or Bi-cortical Osteotomies in the Forefoot
• Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)
• Reconstruction Surgeries of the Foot
• Tibiotalocalcaneal Arthrodesis

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Products listed in Group/Cohort Description — DEVICE
  Depending on approved indication per product

Study Details

The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of the foot; TRIM-IT Drill Pin® system and/or TRIM-IT Spin Pin™ system for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle; Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle; DynaNite® nitinol staple for midfoot and hindfoot arthrodeses or osteotomies, first metatarsophalangeal arthrodesis, and mono or bi-cortical osteotomies in the forefoot; BioComposite SutureTak® anchor for medial ankle stabilization; Beveled FT Screws for hallux valgus repair; KreuLock™ screws for ankle fractures; ArthroFLEX® dermal allograft for hallux rigidus arthroplasty; and DualCompression Hindfoot Nail for tibiotalocalcaneal arthrodesis.

Key Dates

Start date

Dec 1, 2020

Status verified

Jun 2025

Primary completion

Dec 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

700 participants (estimated)

Arms

• Arm: All Products listed in Descriptions
  * ProStop * BioCompression Screw * TRIM-IT Drill Pin/TRIM-IT Spin Pin * Headless Compression Screw/Compression FT Screw * DynaNite Nitinol Staple * BioComposite SutureTak Anchor * Beveled Headed FT Screw * KreuLock Screws * ArthroFLEX dermal allograft * DualCompression Hindfoot Nail

Primary Outcome Measure

To assess change in Visual Analogue Scale (VAS) survey [ Time Frame: preoperatively, 3 months, 6 months and 12 months post operative ]

Central Contacts

• Justin Moss, DHSc
  770 584 4972
  [email protected]

Locations (5)

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