Outcome after Akin osteotomy with suture refixation vs. nitinol staples.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024572

Enrollment

164

Registered

2021-03-22

Start date

2021-07-19

Completion date

Unknown

Last updated

2026-03-30

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: In patients undergoing surgical correction of hallux valgus deformity, Akin osteotomy is performed using NiTinol staples. Patients are clinically examined, x-rayed, and scores are collected (

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Patients with indication for Akin osteotomy - Age 18-80 years

Exclusion criteria

Exclusion criteria: - Florid infection - Fractures that occurred less than 6 months ago - Arthrodesis or osteotomy proximal to the Lisfranc joint row - Wheelchair requirement

Design outcomes

Primary

Measure	Time frame
Bony consolidation after Akin osteotomy (unconsolidated is defined as a visible osteotomy gap >1mm on radiographic follow-up twelve weeks postoperatively).	—

Secondary

Measure	Time frame
- Determination of the frequency of implant-associated complaints (e.g. painful metal) - Revision rate and implant survival time (including a comparison with regard to risk factors and pre-existing conditions) - Visual Analog Scale (VAS) for pain (1-10) at rest and during weight bearing/walking - European Foot and Ankle Society Score (EFAS) - Foot and Ankle Outcome Score (FAOS) - Range of motion (measured with goniometer) - Adverse events (influence of risk factors and previous diseases, if applicable) - Operation time - Cost of surgery - Length of hospital stay	—

Measure

Time frame

- Determination of the frequency of implant-associated complaints (e.g. painful metal) - Revision rate and implant survival time (including a comparison with regard to risk factors and pre-existing conditions) - Visual Analog Scale (VAS) for pain (1-10) at rest and during weight bearing/walking - European Foot and Ankle Society Score (EFAS) - Foot and Ankle Outcome Score (FAOS) - Range of motion (measured with goniometer) - Adverse events (influence of risk factors and previous diseases, if applicable) - Operation time - Cost of surgery - Length of hospital stay

—

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: Apr 4, 2026