Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis.

ABSTRACT:

Background

A novel biointegrative implant was developed for proximal interphalangeal joint (PIPJ) arthrodesis to treat hammertoe deformity. Composed of continuous reinforcing mineral fibers bound by bioabsorbable polymer matrix, the implant demonstrated quiescent, gradual degradation with complete elimination at 104 weeks in animal models. This prospective trial assessed the implant's safety, clinical performance, and fusion rate of PIPJ arthrodesis for hammertoe correction.

Methods

Twenty-five patients (mean age 63.9±7.5 years) who required PIPJ arthrodesis were enrolled at 3 centers. Outcomes included radiographic joint fusion, adverse events, pain visual analog scale (VAS) score, Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) score, and patient sat

SUBMITTER: Cicchinelli LD 

PROVIDER: S-EPMC8564933 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature