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

NCT05643079 | Recruiting

• 1 other identifier: FDLTransferSharkScrew
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

human allogeneic cortical bone screw; Shark Screw®; flat foot deformity; FDL Transfer; Tibialis posterior dysfunction; metal screw; Bio-Tenodesis screw; flat foot

Outcome Measures

Primary Outcomes (2)

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

  bony union will be evaluated

  6 weeks, 6 months, 1 year, 2 years

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

  bony union will be evaluated

  6 months, 1 year

Secondary Outcomes (7)

• changes in AOFAS score in comparison to presurgery

  6 months, 1 year and 2 years

• changes in Foot and Ankle Outcome Score (FOAS) score in comparison to presurgery

  6 months, 1 year and 2 years

• changes in FFI score in comparison to presurgery

  6 months, 1 year and 2 years

• changes in Vas-Pain score in comparison to presurgery

  6 weeks, 6 months, 1 year and 2 years

• complications

  during surgery, 6 weeks, 6 months, 1 year and 2 years

Study Arms (2)

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

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®)

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

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

Interventions

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

The calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by\~10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Metal/Bio-Tenodesis screw(MBS). The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a "shuttle suture". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with an MBS in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.

Also known as: Metal/Bio-Tenodesis screw intervention

metal/Bio-Tenodesis group

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

The calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by approx.10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Shark Screw®. The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a "shuttle suture". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with the Shark Screw® in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.

Also known as: Shark Screw® intervention

human, allogeneic cortical bone screw (Shark Screw®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with an indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with/without FDL transfer. The patient has the choice of the treatment method after explanation advantages and disadvantages for each surgery method

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Study Sites (1)

Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising

Vienna, 1130, Austria

RECRUITING

Related Publications (9)

• Pastl K, Pastl E, Flory D, Borchert GH, Chraim M. Arthrodesis and Defect Bridging of the Upper Ankle Joint with Allograft Bone Chips and Allograft Cortical Bone Screws (Shark Screw(R)) after Removal of the Salto-Prosthesis in a Multimorbidity Patient: A Case Report. Life (Basel). 2022 Jul 11;12(7):1028. doi: 10.3390/life12071028.

  PMID: 35888116 BACKGROUND

• Pastl K, Schimetta W. The application of an allogeneic bone screw for osteosynthesis in hand and foot surgery: a case series. Arch Orthop Trauma Surg. 2022 Oct;142(10):2567-2575. doi: 10.1007/s00402-021-03880-6. Epub 2021 Apr 8.

  PMID: 33834287 BACKGROUND

• Brcic I, Pastl K, Plank H, Igrec J, Schanda JE, Pastl E, Werner M. Incorporation of an Allogenic Cortical Bone Graft Following Arthrodesis of the First Metatarsophalangeal Joint in a Patient with Hallux Rigidus. Life (Basel). 2021 May 24;11(6):473. doi: 10.3390/life11060473.

  PMID: 34073841 BACKGROUND

• Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.

  PMID: 2912622 BACKGROUND

• Obwegeser JA. [Absorbable and bioconvertible osteosynthesis materials in maxillofacial surgery]. Mund Kiefer Gesichtschir. 1998 Nov;2(6):288-308. doi: 10.1007/s100060050077. German.

  PMID: 9880999 BACKGROUND

• Hanslik-Schnabel B, Flory D, Borchert GH, Schanda JE. Clinical and Radiologic Outcome of First Metatarsophalangeal Joint Arthrodesis Using a Human Allogeneic Cortical Bone Screw. Foot Ankle Orthop. 2022 Jul 29;7(3):24730114221112944. doi: 10.1177/24730114221112944. eCollection 2022 Jul.

  PMID: 35924004 BACKGROUND

• Amann P, Pastl K, Neunteufel E, Bock P. Clinical and Radiologic Results of a Human Bone Graft Screw in Tarsometatarsal II/+III Arthrodesis. Foot Ankle Int. 2022 Jul;43(7):913-922. doi: 10.1177/10711007221081533. Epub 2022 Apr 2.

  PMID: 35373594 BACKGROUND

• Sailer S, Lechner S, Flossmann A, Wanzel M, Habeler K, Krasny C, Borchert GH. Treatment of scaphoid fractures and pseudarthroses with the human allogeneic cortical bone screw. A multicentric retrospective study. J Orthop Traumatol. 2023 Feb 10;24(1):6. doi: 10.1186/s10195-023-00686-7.

  PMID: 36765020 BACKGROUND

• Krasny C, Radda C, Polke R, Schallmayer D, Borchert GH, Albrecht C. A human, allogeneic cortical bone screw for distal interphalangeal joint (DIP) arthrodesis: a retrospective cohort study with at least 10 months follow-up. Arch Orthop Trauma Surg. 2023 Jul;143(7):4557-4564. doi: 10.1007/s00402-023-04785-2. Epub 2023 Feb 9.

  PMID: 36757467 BACKGROUND

MeSH Terms

Conditions

Flatfoot; Posterior Tibial Tendon Dysfunction; Foot Deformities

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Foot Diseases

Study Officials

• Florian Wenzel-Schwarz, MD

  Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Wenzel-Schwarz, MD

CONTACT

+43180182; florian.wenzel-schwarz@oss.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician Dr. med.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: December 8, 2022
• Study Start: February 10, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)