ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

NCT06357091 | Recruiting

• 1 other identifier: 1097/2023 ACL-Shark Screw®
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery. the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low

Conditions

Anterior Cruciate Ligament Reconstruction; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Keywords

ACL; tunnel widening; human allogeneic cortical bone screw; Shark Screw®; biotenodese screw; re-rupture rate; IKDC; KOOS; Lysholm Knee Score; Tegner Activity Score; range of motion (ROM)

Outcome Measures

Primary Outcomes (1)

• bone tunnel widening will be measured by CT and/or MRI and measured in mm

  bone tunnel widening will be evaluated and measured by CT and/or MRI and measured in mm

  immadiately after surgery, 3, 6, 12 and 24 months after surgery.

Secondary Outcomes (4)

• International Knee Documentation Committee (IKDC) Scores

  before surgery and 6, 12 and 24 months after surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores

  before surgery and 6, 12 and 24 months after surgery

• Lysholm Knee Score

  before surgery and 6, 12 and 24 months after surgery

• Tegner Activity Score

  before surgery and 6, 12 and 24 months after surgery

Study Arms (2)

ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®)

EXPERIMENTAL

The sugery techniqueis the same for both arms. An allograft screw (Shark Screw ACL®; Surgebright GmbH, A-4040 Lichtenberg, Austria) is used. At the beginning of the operation, the diagnosis is confirmed arthroscopically. The tendon is prepared. The bone tunnels will be created due to the size of the graft. The graft is pulled in and fixed with the intereference screw (Shark Screw ACL®). The tibial bone tunnel will be filled with cancellous chips. Finally, the graft is checked for strength and possible anterior or lateral pinching. The arthroscopic fluid is aspirated and the wound is closed.

Procedure: ACL reconstruction with Shark Screw ACL®

ACL reconstruction with Mecta Composite interference screw

ACTIVE COMPARATOR

The sugery techniqueis the same for both arms. A Mecta-composite-screw, (Medacta, Castello San Pietro, Swiss) is used. At the beginning of the operation, the diagnosis is confirmed arthroscopically. The tendon is prepared. The bone tunnels will be created due to the size of the graft. The graft is pulled in and fixed with the intereference screw (Mecta-composite-screw, Medacta). The tibial bone tunnel will be filled with cancellous chips. Finally, the graft is checked for strength and possible anterior or lateral pinching. The arthroscopic fluid is aspirated and the wound is closed.

Procedure: ACL reconstruction with biocomposite screw (Mecta)

Interventions

ACL reconstruction with Shark Screw ACL® PROCEDURE

ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening

ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®)

ACL reconstruction with biocomposite screw (Mecta) PROCEDURE

ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening

ACL reconstruction with Mecta Composite interference screw

Eligibility Criteria

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

You may qualify if:

• MRI-verified rupture of the anterior cruciate ligament
• Indication for replacement surgery
• Surgery within 6 months of injury
• Uninjured contralateral knee

You may not qualify if:

• Previous rupture of the anterior cruciate ligament on the side to be operated on (rerupture)
• Primary bone disease
• inflammatory disease
• Unstable meniscus
• complete rupture of a collateral ligament
• early rerupture during the examination period (early rerupture)

Sponsors & Collaborators

• Alexander Rofner-Moretti: lead

Study Sites (1)

Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H

Schwaz, Tyrol, 6130, Austria

RECRUITING

Related Publications (25)

• 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

• 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

• 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

• 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

• 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

• Mayr R, Smekal V, Koidl C, Coppola C, Eichinger M, Rudisch A, Kranewitter C, Attal R. ACL reconstruction with adjustable-length loop cortical button fixation results in less tibial tunnel widening compared with interference screw fixation. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1036-1044. doi: 10.1007/s00167-019-05642-9. Epub 2019 Aug 1.

  PMID: 31372680 BACKGROUND

• Yumashev AV, Baltina TV, Babaskin DV. Outcomes after arthroscopic revision surgery for anterior cruciate ligament injuries. Acta Orthop. 2021 Aug;92(4):443-447. doi: 10.1080/17453674.2021.1897744. Epub 2021 Mar 19.

  PMID: 33739222 BACKGROUND

• Webster KE, Feller JA, Hameister KA. Bone tunnel enlargement following anterior cruciate ligament reconstruction: a randomised comparison of hamstring and patellar tendon grafts with 2-year follow-up. Knee Surg Sports Traumatol Arthrosc. 2001;9(2):86-91. doi: 10.1007/s001670100191.

  PMID: 11354858 BACKGROUND

• Linn RM, Fischer DA, Smith JP, Burstein DB, Quick DC. Achilles tendon allograft reconstruction of the anterior cruciate ligament-deficient knee. Am J Sports Med. 1993 Nov-Dec;21(6):825-31. doi: 10.1177/036354659302100611.

  PMID: 8291633 BACKGROUND

• Fahey M, Indelicato PA. Bone tunnel enlargement after anterior cruciate ligament replacement. Am J Sports Med. 1994 May-Jun;22(3):410-4. doi: 10.1177/036354659402200318.

  PMID: 8037283 BACKGROUND

• Taketomi S, Inui H, Yamagami R, Nakazato K, Kawaguchi K, Kono K, Sameshima S, Kage T, Tanaka S. Lateral posterior tibial slope does not affect femoral but does affect tibial tunnel widening following anatomic anterior cruciate ligament reconstruction using a Bone-Patellar Tendon-Bone graft. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2022 Oct 5;30:25-31. doi: 10.1016/j.asmart.2022.09.003. eCollection 2022 Oct.

  PMID: 36254269 BACKGROUND

• Fauno P, Kaalund S. Tunnel widening after hamstring anterior cruciate ligament reconstruction is influenced by the type of graft fixation used: a prospective randomized study. Arthroscopy. 2005 Nov;21(11):1337-41. doi: 10.1016/j.arthro.2005.08.023.

  PMID: 16325084 BACKGROUND

• Lee DK, Kim JH, Lee BH, Kim H, Jang MJ, Lee SS, Wang JH. Influence of Graft Bending Angle on Femoral Tunnel Widening After Double-Bundle ACL Reconstruction: Comparison of Transportal and Outside-In Techniques. Orthop J Sports Med. 2021 Oct 22;9(10):23259671211035780. doi: 10.1177/23259671211035780. eCollection 2021 Oct.

  PMID: 34708137 BACKGROUND

• Moon HS, Choi CH, Yoo JH, Jung M, Lee TH, Choi KH, Kim SH. The Graft Insertion Length in the Femoral Tunnel During Anterior Cruciate Ligament Reconstruction With Suspensory Fixation and Tibialis Anterior Allograft Does Not Affect Surgical Outcomes but Is Negatively Correlated With Tunnel Widening. Arthroscopy. 2021 Sep;37(9):2903-2914.e1. doi: 10.1016/j.arthro.2021.03.072. Epub 2021 Apr 20.

  PMID: 33887417 BACKGROUND

• Nakazato K, Taketomi S, Inui H, Yamagami R, Kawaguchi K, Tanaka S. Lateral posterior tibial slope and length of the tendon within the tibial tunnel are independent factors to predict tibial tunnel widening following anatomic anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2021 Nov;29(11):3818-3824. doi: 10.1007/s00167-020-06419-1. Epub 2021 Jan 18.

  PMID: 33459832 BACKGROUND

• Cavaignac E, Mesnier T, Marot V, Fernandez A, Faruch M, Berard E, Sonnery-Cottet B. Effect of Lateral Extra-articular Tenodesis on Anterior Cruciate Ligament Graft Incorporation. Orthop J Sports Med. 2020 Nov 30;8(11):2325967120960097. doi: 10.1177/2325967120960097. eCollection 2020 Nov.

  PMID: 33299900 BACKGROUND

• de Beus A, Koch JE, Hirschmann A, Hirschmann MT. How to evaluate bone tunnel widening after ACL reconstruction - a critical review. Muscles Ligaments Tendons J. 2017 Sep 18;7(2):230-239. doi: 10.11138/mltj/2017.7.2.230. eCollection 2017 Apr-Jun.

  PMID: 29264333 BACKGROUND

• Han DL, Nyland J, Kendzior M, Nawab A, Caborn DN. Intratunnel versus extratunnel fixation of hamstring autograft for anterior cruciate ligament reconstruction. Arthroscopy. 2012 Oct;28(10):1555-66. doi: 10.1016/j.arthro.2012.02.021. Epub 2012 May 4.

  PMID: 22560484 BACKGROUND

• Ilahi OA, Nolla JM, Ho DM. Intra-tunnel fixation versus extra-tunnel fixation of hamstring anterior cruciate ligament reconstruction: a meta-analysis. J Knee Surg. 2009 Apr;22(2):120-9. doi: 10.1055/s-0030-1247736.

  PMID: 19476176 BACKGROUND

• Brand J Jr, Weiler A, Caborn DN, Brown CH Jr, Johnson DL. Graft fixation in cruciate ligament reconstruction. Am J Sports Med. 2000 Sep-Oct;28(5):761-74. doi: 10.1177/03635465000280052501.

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  PMID: 19910779 BACKGROUND

• Anderson MJ, Browning WM 3rd, Urband CE, Kluczynski MA, Bisson LJ. A Systematic Summary of Systematic Reviews on the Topic of the Anterior Cruciate Ligament. Orthop J Sports Med. 2016 Mar 15;4(3):2325967116634074. doi: 10.1177/2325967116634074. eCollection 2016 Mar.

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• Rahr-Wagner L, Lind M. The Danish Knee Ligament Reconstruction Registry. Clin Epidemiol. 2016 Oct 25;8:531-535. doi: 10.2147/CLEP.S100670. eCollection 2016.

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• Filbay SR, Grindem H. Evidence-based recommendations for the management of anterior cruciate ligament (ACL) rupture. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):33-47. doi: 10.1016/j.berh.2019.01.018. Epub 2019 Feb 21.

  PMID: 31431274 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Alexander Rofner-Moretti, MD

  Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Rofner-Moretti, MD

CONTACT

+435242600; alexander.rofner-moretti@kh-schwaz.at

Markus Reichkendler, MD

CONTACT

+435242600; markus.reichkendler@kh-schwaz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physician Dr. med. Alexander Rofner-Moretti

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: April 10, 2024
• Study Start: February 16, 2026
• Primary Completion (Estimated): January 31, 2034
• Study Completion (Estimated): January 31, 2034
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)