The Use of Magnesium (Mg)-Based Absorbable DrillPins in Hammertoe Deformity Correction: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Number of participants with pain score <3 on the Visual Analogue Scale (VAS) (criterion of successful implantation)
研究概览
简要总结
This is a prospective, single-arm clinical feasibility study evaluating the safe application of a novel lean absorbable magnesium-zinc-calcium alloy (ZX00) drill pin (RemeOs™ DrillPin) for the surgical correction of hammertoe deformities. A total of 20 adult patients will be enrolled. All participants will receive the investigational implant without a comparator or control group. The study focuses on feasibility, safety, and functional outcomes following implantation.
详细描述
This single-arm, open-label, monocenter clinical investigation is conducted in accordance with ISO 14155 to evaluate the safety and performance of the RemeOs™ DrillPin, an absorbable magnesium-zinc-calcium alloy (ZX00) implant, for internal fixation during hammertoe correction surgery in adult patients.
Eligible participants are adults aged 18 years and older with hammertoe deformity of the lesser toes requiring surgical correction, with or without concomitant hallux valgus surgery. The RemeOs™ DrillPin is designed to provide mechanical stability during osteotomy healing and gradually resorbs over time, potentially eliminating the need for implant removal and reducing infection risk through primary wound closure.
Primary objectives include assessing implantation success-defined as low pain levels (VAS <3) and good or fair toe alignment according to the AOFAS Lesser Metatarsophalangeal-Interphalangeal Scale (AOFAS-LMIS)-at 12 weeks postoperatively, as well as short-term safety, measured by the incidence of adverse and serious adverse device events (ADEs/SADEs).
Secondary assessments include clinical evaluation of pain, wound healing, DIP joint function, and neurovascular status at 2, 4, 6, and 12 weeks, and at 12 and 36 months. Radiographic assessments will monitor alignment, gas formation, and osteolysis at each follow-up, with CT imaging at 12 and 36 months to evaluate implant resorption and potential local effects.
This feasibility study aims to generate initial clinical data on the use of absorbable magnesium-based implants in forefoot surgery and to assess their potential to maintain deformity correction without the need for implant retrieval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hammertoe deformity of the lesser toes, with or without accompanying surgery of a hallux valgus deformity
- •Written informed consent of the participant
- •Female and male patients aged 18 years and more
- •Subject has been informed of the nature of the study, agrees to participate and signs the approved consent form
- •Subject is able and willing to comply with all assessments in the study.
- •Female patients in childbearing age perform a pregnancy test prior to inclusion
排除标准
- •Pathological bone lesions (e.g., bone cysts or osteomyelitis)
- •Underlying diseases (kidney diseases, diabetes mellitus)
- •Chronic alcoholics
- •Severe mental illness
- •Pregnant or breastfeeding women
- •Inability or unwillingness to give informed consent
结局指标
主要结局
Number of participants with pain score <3 on the Visual Analogue Scale (VAS) (criterion of successful implantation)
时间窗: At 12 weeks postoperatively
This outcome is one of two predefined criteria used to determine successful implantation. Pain will be measured using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). A score of less than 3 at 12 weeks postoperatively is considered a successful pain outcome
Number of participants with good or fair alignment on the AOFAS Lesser Metatarsophalangeal-Interphalangeal Scale (AOFAS-LMIS) (criterion of successful implantation)
时间窗: At 12 weeks postoperatively
This is one of two predefined criteria for successful implantation. Toe alignment will be assessed at 12 weeks postoperatively using the alignment domain of the AOFAS-LMIS. In this subscale, alignment is scored as follows: 15 points: Good alignment (toe well aligned) 8 points: Fair alignment (some malalignment without symptoms) 0 points: Poor alignment (obvious symptomatic malalignment) An alignment score of 8 or 15 points is considered a successful outcome.
Number of participants with at least one adverse device event (ADE) or serious adverse device event (SADE)
时间窗: From surgery to 12 weeks postoperatively
This outcome measures the short-term safety of the investigational device. Safety will be assessed by recording the occurrence, type, severity, and investigator-assessed relationship of all adverse device events (ADEs) and serious adverse device events (SADEs) from surgery through 12 weeks postoperatively. Data will be collected through clinical evaluations, subject interviews, and medical record review.
次要结局
- Degree of DrillPin resorption(12 and 36 months postoperatively)
- Number of participants with radiographic evidence of subcutaneous gas formation(12 and 36 months postoperatively)