M20.4 M20.5 M20.6
Conditions
Interventions
Group 1: surgery of lesser toes with magnesium-based PIP arthrodesis
Sponsors
Syntellix AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Orthopaedic Foot & Ankle Society (AOFAS) Lesser Toe Metatasophalangeal-Interphalangeal (MTPIP) Score according to Kitaoka, preoperatively compared with 6 months postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety • Bone fusion at 6 months postoperatively. Imaging will be done according to clinical standard. Routine x-ray is at 6 weeks and 6 months postoperatively and optionally at 3 months postoperatively. • Footwear preoperatively compared with 6 months, 1 year and 2 years postoperatively. • Floor contact of the operated toe under burden in a standing position 6 months, 1 year and 2 years postoperatively. • Appearance (external aspect) preoperatively compared with 6 months, 1 year and 2 years postoperatively. • AOFAS MTPIP Score 1 year and 2 years postoperatively. • Satisfaction (AOFAS MTPIP Score = 80) preoperatively compared with 6 months, 1 year and 2 years postoperatively. • AOFAS Hallux MTP-IP Score according to Kitaoka preoperatively compared with 6 months, 1 year and 2 years postoperatively. • European Foot and Ankle Society (EFAS) Score in its validated German version preoperatively compared with 6 months, 1 year and 2 years postoperatively. • Total score of the Foot Function Index (FFI-D) in its validated German version preoperatively compared with 6 months, 1 year and 2 years postoperatively. • Domains pain and function of the FFI-D preoperatively compared with 6 months, 1 year and 2 years postoperatively. • Freedom from pain 6 months, 1 year and 2 years postoperatively, measured with the domain pain of the FFI-D. • Quality of life, as measured with the EQ-5D-5L in its validated German version preoperatively compared with 6 months, 1 year and 2 years postoperatively. | — |
Countries
Germany
Contacts
Public ContactKatja Krockenberger
AMEDON GmbH
Outcome results
None listed