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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020244

Enrollment

Registered

2019-12-06

Start date

2020-01-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M20.4 M20.5 M20.6

Interventions

Group 1: Patients with hammer- resp. claw toes and treated surgically with MAGNEZIX will be requested to answer the questions of the American Orthopaedic Foot & Ankle Society (AOFAS) Lesser Toe Metata

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactHubert O. Klauser

HAND- UND FUSSZENTRUM BERLIN

sekretariat@hfz-berlin.de030 8533072

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026