The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
The main questions it aims to answer are:
Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.
between 18 and 85
confirmed Hallux Valgus
<18 years and >85 years
Known underlying oncological disease
Pregnant women or breastfeeding mothers
Alcohol and drug abuse
Parallel
Hallux Valgus Treatment with Shark Screw®
Procedure/SurgeryThis 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.
Hallux Valgus Treatment with metal screw
Procedure/SurgeryThis 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.
clinical result of Hallux Valgus treatment
The primary objective of the study is the longitudinal evaluation of clinical outcomes (pain, appearance) over 2 years after hallux correction using a human, allogenic, bone screw or metal screw.
radiological (bony union)result of Hallux Valgus treatment
The secondary aim of the study is the longitudinal evaluation of the radiological results over one year after hallux correction using a human, allogenic, bone screw or metal screw compared to pre-surgery values.
change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)
The change in forefoot-AOFAS will be evaluated, between groups and in comparison to pre-surgery
Hallux-Valgus angle (HVA) change
Comparison of HVA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data
gait analysis
Number of patients with normal gait in the two groups and in comparison to a healthy cohort
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
