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Clinical and radiological outcome after TMT-I arthrodesis using a fixed-angle plate system

Clinical and radiological outcome after TMT-I arthrodesis using a fixed-angle plate system

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023632
Enrollment
60
Registered
2021-01-15
Start date
2018-11-19
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

M20.1

Interventions

Group 1: Patients with a severe hallux valgus deformity or TMT instability, in whom the indication for TMT-I arthrodesis has been given, are surgically treated with the APTUS Foot, Tri Lock implants (

Sponsors

Medizinische Hochschule Hannover
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Symptomatic hallux valgus treated with TMT1 arthrodesis - Primary procedure

Exclusion criteria

Exclusion criteria: - Age under 18 years - Wheelchair requirement - Further arthroses (TMT II/III, NC, TN, USG/OSG) - Relevant deformities of the midfoot or hindfoot - Previous operations for hallux valgus correction - Previous revision surgery

Design outcomes

Primary

MeasureTime frame
Does the non-union rate differ when using the Tri Lock implants, the technique used in the MHH orthopedic clinic at Diakovere Annastift, from the values reported in the literature.

Secondary

MeasureTime frame
Comparison of the postoperative intermetatarsal 1-2 angles in loaded radiographs achieved with the technique used in the MHH Orthopaedics Department at Diakovere Annastift compared to the literature. 1. comparison of the achieved clinical results with the values in the literature: a. FAOS (Foot and Ankle Outcome Score). b. NRS c. Satisfaction d. Metal removal rate e. Complications especially wound healing disorders f. Rate of irriations of the tibialis ant tendon g. Frequency of sesamoiditis 2. do the plate systems used differ with regard to the above parameters?

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

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