Follow-up study on arthrodeses of the proximal interphalangeal joint (PIP-arthrodeses) using biodegradable magnesium-based PIP implants for the treatment of lesser toe deformities.

• Conditions: M20.6; M20.4; M20.5; Other hammer toe(s) (acquired); Other deformities of toe(s) (acquired); Acquired deformity of toe(s), unspecified

• Registration Number: DRKS00020244
• Lead Sponsor: Syntellix AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-06
• Study Completion: 2020-02-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

•Proximal interphalangeal joint fusion of one or more lesser toes (claw toe or hammer toe) by PIP arthrodesis surgery with MAGNEZIX® StarFuse® with or without concurrent hallux valgus surgery or other associated operations.
•Age =18 years.
•Written informed consent.
•Arthrodesis surgery before October 1st, 2019

Exclusion Criteria

•Patients unable to consent and understanding the purpose as well the consequences of this study
•Employment relationship or other dependency with the Sponsor or investigator

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot & Ankle Society (AOFAS) Lesser Toe Metatarsophalangeal-Interphalangeal (MTPIP) Score according to Kitaoka at follow-up

Secondary Outcome Measures

Name	Time	Method
•Adverse device effect (ADE) during surgery.<br>•ADE during wound healing, e.g., infection or delayed wound healing.<br>•Serious adverse event (SAE) between surgery and follow-up, including revision surgery.<br>•Swelling of the foot, measured with a measuring tape at follow-up.<br>•Satisfaction (AOFAS MTPIP Score = 80) at follow-up.<br>•Standard deviation scores (SDS) calculated from the German age-related normative values for the AOFAS MTPIP Score at follow-up.<br>•Total score and domains of the Foot Function Index (FFI-D) in its validated German version in its validated German version at follow-up.<br>•Standard deviation scores (SDS) calculated from the German age-related normative values for the FFI-D at follow-up.