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

NCT06262204 | Not Yet Recruiting

• 1 other identifier: Hallux Shark Screw(R)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

Hallux Valgus; human allogeneic cortical bone screw; Shark Screw®; HVA; IMA; AOFAS; time to union; union rate; FFI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• radiological (bony union)result of Hallux Valgus treatment

  1 years

• change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)

  2 years

• Hallux-Valgus angle (HVA) change

  2 years

• gait analysis

  2 years

• Intermetatarsal angle (IMA) change

  2 years

Study Arms (2)

conventional group

OTHER

standard surgery with metal screw

Procedure: Hallux Valgus Treatment with metal screw

Shark Screw® group

EXPERIMENTAL

new surgical procedure with human allogeneic cortical bone screw

Procedure: Hallux Valgus Treatment with Shark Screw®

Interventions

Hallux Valgus Treatment with Shark Screw® 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

Hallux Valgus Treatment with metal screw 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.

conventional group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 85
• confirmed Hallux Valgus

You may not qualify if:

• \<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

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Study Sites (1)

Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Florian Wenzel-Schwarz, MD

  Orthopädisches Spital Speising

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Wenzel-Schwarz, MD

CONTACT

+43180182; florian.wenzel@oss.at

Andreas Kranzl, PhD

CONTACT

Andreas.Kranzl@oss.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: does get the information only after 2 years at the end of teh study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 15, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)