Medial Displacement Calcaneal Osteotomy and FDL- Transfer - a Prospective Comparative Study Between Metal/Bio-Tenodesis Screw (Arthrex) and the Human, Allogeneic Cortical Bone Screw (Shark Screw®️, Surgebright-GmbH)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
RECRUITING
Vienna
Contact Information
Primary
Florian Wenzel-Schwarz, MD
florian.wenzel-schwarz@oss.at
+43180182
Time Frame
Start Date: 2022-02-10
Estimated Completion Date: 2028-02
Participants
Target number of participants: 40
Treatments
metal/Bio-Tenodesis group
medializing calcaneal osteotomy, debridement of the tibialis posterior tendon, and/or transfer of the flexor digitorum longus (FDL) tendon with the following screws:~Metal-/Bio-Tenodesis screw (Arthrex, Naples, Florida, USA)~Metal-Screw:~ø 6,7 mm length: 40-60 mm~Bio-Tenodesis screw:~ø 4,00 mm, length: 10 mm ø 4,75 mm, length: 15 mm ø 5,50 mm, length: 15 mm
human, allogeneic cortical bone screw (Shark Screw®)
medializing calcaneal osteotomy, debridement of the tibialis posterior tendon, and/or transfer of the flexor digitorum longus (FDL) tendon with the following screws:~Shark Screw® (Surgebright-GmbH, 4040 Lichtenberg, Austria)~Versions used:~Shark Screw® diver ø: 5,0 mm, length: 35 mm Shark Screw® diver ø: 5,0 mm, length: 45 mm Shark Screw® tendon ø: 5,0 mm, length: 15 mm
Related Therapeutic Areas
Sponsors
Leads: Orthopedic Hospital Vienna Speising

This content was sourced from clinicaltrials.gov