A PMCF-study on bioresorbable mm.PIP implant for the correction of lesser toe deformities - PIP01 / mm.PIP study

Medical Magnesium GmbH0 个研究点目标入组 40 人开始时间: 2021年6月11日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patient is able to give and provided informed consent for study participation
•Patient requires surgical correction of hammer or claw toes either isolated or in conjunction with distal Hallux valgus surgery
•Ability and willingness to adhere to study follow-up

•Contraindications for mm.PIP as indicated in the instructions for use
•Patient of a vulnerable group:
•Patients with incurable diseases;
•Patients in nursing homes;
•Patients in emergency situations;
•Homeless, nomads or refugees;
•Dislocation of the metatarsophalangeal joint (MTP joint)
•Complex regional pain syndrome
•Known allergy to the study device and or any of its components
•Fracture or deformities of accompanying bones (e.g. metatarsal bones)
•In the opinion of the investigator, patient has an emotional or neurological condition that would pre-empt their willingness to participate in the study, including mental illness, drug or alcohol abuse
•Patient is entered in another investigational drug or device study, or has been treated with an investigational product in the past 30 days
•Patient is suffering from restricted mobility that may impair post-operative healing
•Patient is known to be at risk for loss to follow-up or failure to return for scheduled study visits
•Patient is personally dependent on the investigator or the sponsor of the study

发起方