Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hallux Valgus Treatment with Shark Screw®, Hallux Valgus Treatment with metal screw.
- Who it may be relevant to
- Registry conditions: Hallux Valgus. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study
Overview
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.
Interventions
- 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 s - 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 s
Primary outcome measures
- clinical result of Hallux Valgus treatment [Time frame: 2 years]
Secondary outcome measures (5)
- radiological (bony union)result of Hallux Valgus treatment [Time frame: 1 years]
- change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS) [Time frame: 2 years]
- Hallux-Valgus angle (HVA) change [Time frame: 2 years]
- gait analysis [Time frame: 2 years]
- Intermetatarsal angle (IMA) change [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising — Vienna
Identifiers
NCT: NCT06262204 · Hallux Shark Screw(R)