Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 40
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Orthopedic Hospital Vienna SpeisingUpdated: Apr 2, 2026Locations: 1
Eligibility criteria

between 18 and 85 [+1]

<18 years and >85 years [+9]

Status: Recruiting

Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw

The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal/Bio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone. The main questions it aims to answer are: * Can the human bone screw achieve union rates like the metal/Bio-Tenodesis screw? * Is the time to union similar between the different screws? * Is the complication rate similar between the different screws? * Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups? Participants will have * the surgery * follow-ups at 6 weeks, 6 months, 1 and 2 years. * X-rays are performed at each follow up. * CT-scans are performed after 6 months. * activity scores are collected at the follow up after 6 months, 1 year and 2 years.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Orthopedic Hospital Vienna SpeisingUpdated: Mar 20, 2025Locations: 1
Eligibility criteria

Indication for the use of a metal/Bio-Tenodesis screw or human bone screw in med... [+1]

Insufficient knowledge of German [+10]