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

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

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.)

Study Overview

• Status: Recruiting
• 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.)
• Intervention / Treatment: Device: Products listed in Group/Cohort Description

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 Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Justin Moss, DHSc; Phone Number: 770 584 4972; Email: justin.moss@arthrex.com

Study Locations

• Germany
  • Duisburg, Germany, 47169
    • Recruiting
    • OrthoPedes
    • Contact: Manuel Nastai, Dr. medic
    • Principal Investigator: Manuel Nastai, Dr. medic.
• South Africa
  • Durban, South Africa, 3629
    • Recruiting
    • Dr Haroun Mahomed Orthopaedic Practice
    • Contact: Haroun Mahomed, Dr.
    • Principal Investigator: Haroun Mahomed, Dr.
• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Medical Center
      • Contact: Gaby Zumaran
      • Principal Investigator: Christopher Kreulen, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Recruiting
      • TOA Research Foundation
      • Contact: Erika Frazier
      • Principal Investigator: Jeffrey Herring, MD
  • Texas
    • San Antonio, Texas, United States, 78258
      • Terminated
      • Barrett Podiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Approximately 50 subjects, male and female,18 years of age or older will be enrolled for each product and material with the exception of ProStop which includes subjects age >two to 17 years of age. Subjects will be recruited from the surgeon's patient population.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Products listed in Group/Cohort Description; Depending on approved indication per product

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion; Hallux Varus
• Other Study ID Numbers: AIRR-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No