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

Recruiting

• Conditions: First Metatarsophalangeal Arthrodesis; Akin Osteotomy; Hyperpronated Foot; Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle; Mono or Bi-cortical Osteotomies in the Forefoot; Fixation of Small Bone Fragments of the Foot/Ankle; Lisfranc Arthrodesis; Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron); Reconstruction Surgeries of the Foot; Midfoot and Hindfoot Arthrodeses or Osteotomies
• Interventions: Device: Products listed in Group/Cohort Description

• Registration Number: NCT04715139
• Lead Sponsor: Arthrex, Inc.

Brief 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.)

Detailed Description

To assess safety, related adverse events will be evaluated at six months postoperative and at one-year postoperative time points. To evaluate performance, physical exam and imaging of the target area of the body will be evaluated at three months postoperative. Additionally, patient reported outcomes will be evaluated at three months postoperative, six months postoperative and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12) and Foot and Ankle Ability Measures (FAAM).

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion 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

Exclusion Criteria

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)

   (DynaNite Nitinol Staple Subjects ONLY)

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Products listed in Descriptions	Products listed in Group/Cohort Description	* ProStop * BioCompression Screw * TRIM-IT Drill Pin/TRIM-IT Spin Pin * Headless Compression Screw/Compression FT Screw * DynaNite Nitinol Staple * Beveled Headed FT Screw

Primary Outcome Measures

Name	Time	Method
To assess changes in Veterans RAND Health (VR-12) survey	preoperatively, 3 months, 6 months and 12 months post operative	Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
To assess change in Visual Analogue Scale (VAS) survey	preoperatively, 3 months, 6 months and 12 months post operative	Patient reported pain scale 0-10 point scale (0 min, 10 max)
To assess changes in Foot and Ankle Ability Measures (FAAM) survey	preoperatively, 3 months, 6 months and 12 months post operative	Patient reported change to physical function for individuals with foot and ankle related impairments. A higher score represents a higher level of physical function

Trial Locations

Locations (5)

OrthoPedes; 🇩🇪 Duisburg, Germany

TOA Research Foundation; 🇺🇸 Nashville, Tennessee, United States

Dr Haroun Mahomed Orthopaedic Practice; 🇿🇦 Durban, South Africa

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Barrett Podiatry; 🇺🇸 San Antonio, Texas, United States