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

Recruiting

• Conditions: M20.4; M20.5; Other hammer toe(s) (acquired); Other deformities of toe(s) (acquired)

• Registration Number: DRKS00023967
• Lead Sponsor: Medical Magnesium GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success of the joint fusion method up to 6 weeks after surgery, defined by the maintenance of implant integrity and the exclusion of bone end dislocation. Radiological assessment is carried out according to clinical standard.

Secondary Outcome Measures

Name	Time	Method
• Number of ADEs/SADEs up to 6 weeks, 6 months and 12 months after surgery<br>• Clinical success of the joint fusion method up to 6 months and 12 months after surgery, defined by the absence of signs of pseudarthrosis.<br>• Technical success of surgery, defined as:<br>Successful implantation;<br>No damage of implant;<br>No loss of integrity;<br>No exchange of the implant required;<br>• Patient satisfaction, assessed by a Likert scale prior to and at 6 weeks, 6 months and 12 months after surgery<br>• Pain, assessed by VAS and Likert scale prior to and at 6 weeks, 6 months and 12 months after surgery<br>• AOFAS-LMIS score prior to and at 6 weeks, 6 months and 12 months after surgery<br>• Photo documentation prior, during and at 6 weeks, 6 months and 12 months after surgery