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

Not Applicable

Not yet recruiting

• Conditions: Hallux Valgus
• Interventions: Procedure: Hallux Valgus Treatment with metal screw; Procedure: Hallux Valgus Treatment with Shark Screw®

• Registration Number: NCT06262204
• Lead Sponsor: Orthopedic Hospital Vienna Speising

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.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Start: 2025-12-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional group	Hallux Valgus Treatment with metal screw	standard surgery with metal screw
Shark Screw® group	Hallux Valgus Treatment with Shark Screw®	new surgical procedure with human allogeneic cortical bone screw

Primary Outcome Measures

Name	Time	Method
clinical result of Hallux Valgus treatment	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Intermetatarsal angle (IMA) change	2 years	Comparison of IMA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data
change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)	2 years	The change in forefoot-AOFAS will be evaluated, between groups and in comparison to pre-surgery
Hallux-Valgus angle (HVA) change	2 years	Comparison of HVA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data
radiological (bony union)result of Hallux Valgus treatment	1 years	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.
gait analysis	2 years	Number of patients with normal gait in the two groups and in comparison to a healthy cohort

Trial Locations

Locations (1)

Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising; 🇦🇹 Vienna, Austria