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

Description

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.)

Conditions

Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle, 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), Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus, Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)

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Study Overview

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Study Details

Study overview

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.)

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

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

Condition
Hyperpronated Foot
Intervention / Treatment

-

Contacts and Locations

Sacramento

UC Davis Medical Center, Sacramento, California, United States, 95817

Nashville

TOA Research Foundation, Nashville, Tennessee, United States, 37209

San Antonio

Barrett Podiatry, San Antonio, Texas, United States, 78258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant
  • 2. Subject is 18 years of age or over (all products except ProStop)
  • 3. Subject age \>two to 17 years (ProStop product only)
  • 4. Subject is not pregnant, nursing, prisoner, or ward of the state
  • 5. Subject or subject's representative signed informed consent and assent when, applicable, and is willing and able to comply with all study requirements
  • 1. Insufficient quantity or quality of bone
  • 2. Blood supply limitations and previous infections, which may retard healing
  • 3. Foreign-body sensitivity
  • 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 (except for ProStop)
  • 7. Subjects who have a comminuted bone surface that would not allow for staple placement as required by the DynaNite Nitinol Staples directions for use
  • 8. Subjects who have pathologic bone conditions such as osteopenia that would impair the ability to securely fix the implant as required by the DynaNite Nitinol Staples directions for use

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Arthrex, Inc.,

Study Record Dates

2024-12-31