A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational [Patient Registry]
SUMMARY

The objective of the registry is to evaluate the continued safety and performance of the 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, TRIM-IT Spin Pin 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 and DynaNite® Nitinol Staple to be used for fixation such as Lisfranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant

• Subject is 18 years of age or over (all products except ProStop)

• Subject age >two to 17 years (ProStop product only)

• Subject is not pregnant, nursing, prisoner, or ward of the state

• Subject or subject's representative signed informed consent and assent when, applicable, and is willing and able to comply with all study requirements

Locations
United States
Texas
Barrett Podiatry
Recruiting
San Antonio
Other Locations
Germany
OrthoPedes
Not yet recruiting
Duisburg
Contact Information
Primary
Donna Williams, BS,RN,CCRP
donna.williams@arthrex.com
800.933.7001
Time Frame
Start Date: December 1, 2020
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 650
Treatments
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~Beveled Headed FT Screw
Authors
Manuel Nastai
Related Therapeutic Areas
Sponsors
Leads: Arthrex, Inc.

This content was sourced from clinicaltrials.gov

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