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

Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: Hallux Valgus Treatment with metal screw; Procedure: Hallux Valgus Treatment with Shark Screw®

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Wenzel-Schwarz, MD; Phone Number: 3081 +43180182; Email: florian.wenzel@oss.at
• Study Contact Backup: Name: Andreas Kranzl, PhD; Email: Andreas.Kranzl@oss.at

Study Locations

• Austria
  • Vienna, Austria, 1130
    • Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
    • Contact: Florian Wenzel-Schwarz, MD; Phone Number: 3081 +43180182; Email: florian.wenzel-schwarz@oss.at
    • Principal Investigator: Florian Wenzel-Schwarz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventional group; standard surgery with metal screw	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.
Experimental: Shark Screw® group; new surgical procedure with human allogeneic cortical bone screw	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 years
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	2 years
gait analysis	Number of patients with normal gait in the two groups and in comparison to a healthy cohort	2 years
Intermetatarsal angle (IMA) change	Comparison of IMA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data	2 years
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	2 years

Collaborators and Investigators

• Sponsor: Orthopedic Hospital Vienna Speising
• Investigators: Principal Investigator: Florian Wenzel-Schwarz, MD, Orthopädisches Spital Speising

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Hallux Valgus; IMA; human allogeneic cortical bone screw; Shark Screw®; AOFAS; HVA; time to union; union rate; FFI
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: Hallux Shark Screw(R)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to sensitivity of Data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No