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

NCT ID: NCT06262204

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-31

Brief Summary

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.

Detailed Description

The planned prospective study will investigate whether the use of the human allogenic cortical bone screw (Shark Screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. Furthermore, it will be investigated whether rotational stability is possible with the bone screw. The measurement of the HVA angle and the IMA angle should provide information on whether the correction is stable over time. A comparison of the AOFAS forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results.

Initial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . A retrospective study by Hanslik-Schnabel et al has shown initial positive results in the treatment of hallux rigidus. In addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3D gait analysis/pedobarography and is also matched with another healthy cohort.

At the preoperative time point and after 12 and 24 months, a 3D gait analysis with a foot model is conducted to record the joint kinematics and kinetics. In the study by Canseco et al. , the proximal gait pattern changes remained unchanged. Hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux MP joint in the terminal standing phase.

Conditions

Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional group

standard surgery with metal screw

Group Type: OTHER

Hallux Valgus Treatment with metal screw

Intervention Type: PROCEDURE

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.

Shark Screw® group

new surgical procedure with human allogeneic cortical bone screw

Group Type: EXPERIMENTAL

Hallux Valgus Treatment with Shark Screw®

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• between 18 and 85
• confirmed Hallux Valgus

Exclusion Criteria

• <18 years and >85 years
• Known underlying oncological disease
• Pregnant women or breastfeeding mothers
• Alcohol and drug abuse
• Foreseeable compliance problems
• Foreseeable loss of responsibility as a study doctor
• Neoplastic diseases
• Active osteomyelitis
• Ulcerations in the area of the skin of the surgical site
• Immunosuppressive medication that cannot be discontinued

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Hospital Vienna Speising

OTHER

Sponsor Role: lead

Responsible Party

Forian Wenzel-Schwarz

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florian Wenzel-Schwarz, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopädisches Spital Speising

Locations

Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising

Vienna, , Austria

Countries

Austria

Central Contacts

Florian Wenzel-Schwarz, MD

Role: CONTACT

florian.wenzel@oss.at

+43180182 ext. 3081

Andreas Kranzl, PhD

Role: CONTACT

Andreas.Kranzl@oss.at

Facility Contacts

Florian Wenzel-Schwarz, MD

Role: primary

florian.wenzel-schwarz@oss.at

+43180182 ext. 3081

Other Identifiers

Hallux Shark Screw(R)

Identifier Type: -

Identifier Source: org_study_id