Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).

NANot yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Hallux Valgus
Interventions
PROCEDURE

Hallux Valgus Treatment with Shark Screw®

This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.

PROCEDURE

Hallux Valgus Treatment with metal screw

This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.

Trial Locations (1)

1130

Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, Vienna

All Listed Sponsors
lead

Orthopedic Hospital Vienna Speising

OTHER

NCT06262204 - Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw). | Biotech Hunter | Biotech Hunter