Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up

IF 2.2 3区 医学 Q2 ORTHOPEDICS
Nikke Partio, Ville Mattila, Ville Waris, Heikki Mäenpää
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引用次数: 0

Abstract

Introduction

To assess the feasibility and preliminary clinical outcomes of bioabsorbable screw fixation in first metatarsophalangeal joint arthrodesis compared to conventional titanium screw fixation. Methods: In this prospective pilot randomized controlled trial, 30 patients were allocated 1:1 to bioabsorbable or titanium cannulated lag screw fixation. Arthrodesis was performed using a cup-and-cone technique at two Finnish hospitals. Full weight-bearing in an orthopaedic shoe was allowed after six weeks. Outcomes included AOFAS and VA-FAS FA-VAS scores, union rates, and complications assessed at 3, 6, 12, and 24 months.

Results

Both groups showed significant functional improvement with no between-group differences. At 24 months, mean AOFAS scores were 89.1 (SD 2.7) in the titanium group and 90.0 (SD 0.0) in the bioabsorbable group (p = 0.23). Mean FA-VAS total scores (sum of pain, function, and complaints subscales) were 1948 (SE 59.4) in the titanium group and 1914 (SE 61.4) in the bioabsorbable group (p = 0.655). Union rate was 90% overall; nonunion occurred in one titanium and two bioabsorbable patients, all requiring revision. No implant-related complications or hardware removal surgeries were recorded. Degradation of bioabsorbable screws caused no adverse clinical or radiographic reactions.

Conclusions

Bioabsorbable screws appear safe and feasible in first metatarsophalangeal joint arthrodesis, with preliminary outcomes comparable to titanium fixation. These findings support the conduct of a larger confirmatory trial.

Trial registration

ClinicalTrials.gov, NCT03133039, registered 28 April 2017. https://clinicaltrials.gov/ct2/show/NCT03133039

生物可吸收螺钉与钛螺钉在第一跖趾关节融合术中的对比:一项2年随访的随机对照试验。
前言:评价生物可吸收螺钉固定在第一跖趾关节融合术中的可行性和初步临床效果,并与常规钛螺钉固定进行比较。方法:在这项前瞻性先导随机对照试验中,30例患者按1:1的比例被分配到生物可吸收或空心钛螺钉固定组。在芬兰的两家医院采用杯锥技术进行关节融合术。六周后允许在矫形鞋中完全负重。结果包括AOFAS和VA-FAS FA-VAS评分、愈合率以及3、6、12和24个月的并发症评估。结果:两组患者功能均有明显改善,组间无差异。24个月时,钛组的平均AOFAS评分为89.1 (SD 2.7),生物可吸收组的平均AOFAS评分为90.0 (SD 0.0) (p = 0.23)。平均FA-VAS总评分(疼痛、功能和主诉亚量表的总和)钛组为1948 (SE 59.4),生物可吸收组为1914 (SE 61.4) (p = 0.655)。总结率为90%;1例钛骨和2例生物吸收性骨不愈合,均需要翻修。无种植体相关并发症或硬体移除手术记录。生物可吸收螺钉降解无不良临床或影像学反应。结论:生物可吸收螺钉在第一跖趾关节融合术中是安全可行的,初步结果与钛固定相当。这些发现支持进行更大规模的验证性试验。试验注册:ClinicalTrials.gov, NCT03133039,注册于2017年4月28日。https://clinicaltrials.gov/ct2/show/NCT03133039。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.30
自引率
13.00%
发文量
424
审稿时长
2 months
期刊介绍: "Archives of Orthopaedic and Trauma Surgery" is a rich source of instruction and information for physicians in clinical practice and research in the extensive field of orthopaedics and traumatology. The journal publishes papers that deal with diseases and injuries of the musculoskeletal system from all fields and aspects of medicine. The journal is particularly interested in papers that satisfy the information needs of orthopaedic clinicians and practitioners. The journal places special emphasis on clinical relevance. "Archives of Orthopaedic and Trauma Surgery" is the official journal of the German Speaking Arthroscopy Association (AGA).
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