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

Orthopedic Hospital Vienna Speising

Status: Enrolling

Conditions: Tibialis Posterior Dysfunction; Flexor Tendon Rupture; Deformity, Foot; Flat Feet

Treatments: Procedure: medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®; Procedure: medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with metal/Bio-Tenodesis screws

Study type: Observational

Funder types: Other

Identifiers

NCT05643079

FDLTransferSharkScrew

Details and patient eligibility

About

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.

Full description

Symptomatic flatfoot deformity in adults often occurs as a result of dysfunction of the Tibialis posterior tendon (TPTD), with a prevalence of 3.3%. Structured non-surgical treatment programs with orthotics and physiotherapy can achieve a high level of long-term subjective and functional satisfaction, with surgery being avoided in 70-89% of cases. Surgical intervention is indicated for progressive or uncontrolled symptoms. Flexible flatfoot deformity, stage II classified by Johnson and Strom, can be treated with a joint-preserving strategy, which usually includes a medializing calcaneal osteotomy, debridement of the tibialis posterior tendon, and transfer of the flexor digitorum longus (FDL) tendon. 87% satisfaction after ten years was observed in both pain relief and foot function and alignment.

Metal screws have been used for decades to treat bone fractures. The removal is the major disadvantage of conventional osteosyntheses and requires a second operation, with all the resulting risks of complications for each patient. The use of the bone screw from allogeneic cortical bone would reduce costs substantially, with a significant reduction in the average complication rate to 0.3%.

The idea of stabilizing fractures using compact bone instead of metal is not new. Obwegeser published the clinical use of 796 screw implants of allogeneic bone and reported that the only complication was the fracture of 6 screws (<1%) and three screw loosening (<0,5%).

Since 2016, the human, allogeneic cortical bone screw(Shark Screw®) has been used by two tissue banks, the Austrian Austrian tissue bank Surgebright-GmbH and the German Institute for Cell and Tissue Replacement (DIZG). The Shark Screw® graft was approved by the competent Austrian authority (AGES) in 2016. The bone graft immediately creates a solid, purely bony connection. This leads to bone remodeling, bone incorporation and optimal reparation in the surgical area. Depending on the loads and requirements, the bone connection adapts for the future. The bone grafts undergo a certified sterilization procedure at the DIZG, which was developed in 1985 at the Berlin Charité.

Due to the lack of further systematic investigations to objectively confirm the theoretically given and subjectively experienced product advantages, this observational study is now being conducted.

The aim of the present study is to evaluate the application of the human allogeneic cortical bone screw (Shark Screw®) and the metal/Bio-Tenodesis screw in the surgical treatment (medializing calcaneus osteotomy with FDL transfer) of symptomatic flatfoot and to systematically document corresponding clinical and radiological parameters before and after surgery.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

40 participants in 2 patient groups

metal/Bio-Tenodesis group

Description:

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

Treatment:

Procedure: medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with metal/Bio-Tenodesis screws

human, allogeneic cortical bone screw (Shark Screw®)

Description:

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

Treatment:

Procedure: medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®