Biodegradable magnesium-based PIP arthrodesis for the treatment of lesser toe deformities: a post market clinical follow-up study

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

• Registration Number: DRKS00020121
• Lead Sponsor: Syntellix AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Indication for proximal interphalangeal joint fusion (hammer toe) of lesser toes with or without concurrent hallux valgus surgery.
•Operation technique in case of concurrent hallux valgus surgery on the same foot: Chevron, Chevron/Akin, Scarf or McBride.
•Age =18 years.
•Written informed consent.

Exclusion Criteria

•Pregnancy, suspected pregnancy or breast feeding.
•Severe hallux valgus.
•Concurrent operation on the other foot.
•Osteoporosis.
•Insufficient or avascular bone mass for anchorage of the implant.
•Peripheral arterial occlusive disease.
•Complex regional pain syndrome (CRPS).
•Confirmation or suspected septic infectious surgical site.
•Luxation of the metatarsophalangeal joint.
•Relevant neurological or psychiatric disorder, e.g., epilepsy.
•Restricted mobility which could curtail postoperative healing

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot & Ankle Society (AOFAS) Lesser Toe Metatasophalangeal-Interphalangeal (MTPIP) Score according to Kitaoka, preoperatively compared with 6 months postoperatively.