Dataset Information

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 satisfaction. Patients were evaluated 2, 4, 6, 12, and 26 weeks postoperatively.

Results

Twenty-two patients (88%) achieved radiographic fusion at 26 weeks. All joints (100%) were considered clinically stable, with no complications or serious adverse events. Pain VAS improved from 5.3±2.5 preoperatively to 0.5±1.4 at 26 weeks postoperatively. FAAM-ADL total scores and level of functioning improved by mean 19.5±19.0 points and 24.4±15.7 percentage points, respectively, from preoperation to 26 weeks postoperation. Improvements in pain VAS and FAAM scores surpassed established minimal clinically important differences. All patients were very satisfied (84%) or satisfied (16%) with the surgery. Patient-reported postoperative results greatly exceeded (72%), exceeded (20%), or matched (8%) expectations.

Conclusion

This prospective, multicenter, first-in-human clinical trial of a novel biointegrative fiber-reinforced implant in PIPJ arthrodesis of hammertoe deformity demonstrated a favorable rate of radiographic fusion at 12 and 26 weeks, with no complications and good patient-reported clinical outcomes.

Level of evidence

Level IV, prospective case series.

SUBMITTER: Cicchinelli LD

PROVIDER: S-EPMC8564933 | biostudies-literature |

REPOSITORIES: biostudies-literature

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