Clinical trial NCT04715139: Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Official title: A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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.)
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 650
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: To assess change in Visual Analogue Scale (VAS) survey
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
measure: To assess changes in Veterans RAND Health (VR-12) survey
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
measure: To assess changes in Foot and Ankle Ability Measures (FAAM) survey
timeFrame: preoperatively, 3 months, 6 months and 12 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Nashville
country: United States
facility: TOA Research Foundation
state: Tennessee
city: San Antonio
country: United States
facility: Barrett Podiatry
state: Texas
city: Duisburg
country: Germany
facility: OrthoPedes
city: Durban
country: South Africa
facility: Dr Haroun Mahomed Orthopaedic Practice
Study officials:
References: