RecruitingNot Applicable

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

Austria40 participantsStarted 2022-02-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer. * BMI\< 40 kg/m² Exclusion Criteria: * Insufficient knowledge of German * Alcohol and drug abuse * Pregnant woman or nursing mother * Foreseeable compliance problems * Neoplastic diseases, malignant bone tumors, rheumatoid arthritis * Active osteomyelitis * History of foot surgery * Advanced osteoarthritis of the lower ankle joint * Ulcerations in the skin of the surgical area * Immunosuppressive medications that cannot be discontinued * BMI \>40

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

x-ray qualitative evaluation of changes in bony union of calcaneus osteotomy

Timeframe: 6 weeks, 6 months, 1 year, 2 years

CT-scan qualitative evaluation of changes in bony union of calcaneus osteotomy

Timeframe: 6 months, 1 year

Trial details

NCT IDNCT05643079

SponsorOrthopedic Hospital Vienna Speising

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-02

Contact for this trial

Florian Wenzel-Schwarz, MD

+43180182 florian.wenzel-schwarz@oss.at

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