Clinical trial NCT06357091: ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
Official title: ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injury
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)
Lead sponsor: Bezirkskrankenhaus Schwaz
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Rupture of the anterior cruciate ligament of the knee joint is a common (sports) injury in young adults . Depending on various patient-related factors, such an injury can be treated surgically or conservatively . Arthroscopic and anatomical reconstruction is currently considered the gold standard of surgical treatment. In this procedure, the torn anterior cruciate tendon will be replaced usually with the own semitendinosus ligament, the patellar ligament or the quadriceps tendon by inserting it through bone tunnels in the femur and tibia.

However, the optimal technique for fixing the graft remains unclear. Until the replacement graft has healed, the suspension of the graft remains the weak point of the overall construct . The currently common procedures are fixation by means of interference screw in the bone tunnels and distal fixation using endobuttons. These fixation methods differ only insignificantly in clinical scores, stability, or failure rate .

A frequent complication after reconstruction of the anterior cruciate ligament is secondary tunnel dilatation, which has been described in up to 84% of cases. The cause of this is not yet fully understood. Nakazato et al. cites a longer graft and an increased dorsolateral tibial slope. Taketomi makes the posterior tibial slope particularly responsible for tibial tunnel widening and describes that an osteolysis process occurs due to the penetration of synovial fluid into the space between the tendon and the tunnel . Moon et al. see a negative correlation between the length of the graft insertion and tunnel dilation. The widening of the bone tunnels seem not to induce instability, but complicates a follow-up operation, e.g. a new cruciate ligament plasty in the event of rerupture following new trauma. The often up to twice as large bone tunnels make it difficult to find sufficient bone tissue to create a new tunnel. If the already existing and enlarged tunnel is reused, there is a risk of inadequate fixation and lack of incorporation of the new graft. In the revision, a two-stage procedure is often necessary, especially in the case of pronounced widening of the bone tunnel. The group postulates that with a tunnel width \&amp;amp;amp;gt;14 mm, only a two-stage procedure is possible. In a first operation, the bone tunnel must be filled with autologous or similar, and only in a second session a new reconstruction of the anterior cruciate ligament can be attempted.

the investigators are planning a prospective, randomized, controlled, single-blind and monocentric study with 2 parallel groups to investigate an alternative fixation method in cruciate ligament surgery. This involves a screw made from allogenic bone (Shark Screw ACL®; Surgebright GmbH, A-4040 Lichtenberg, Austria) in the form of an interference screw obtained from donor cortical bone. The insertion of this bone screw is identical to the usual interference screws. This type of osteosynthesis material has already proven in other forms in fracture treatment. The investigators have been using screws made from allogenic bone in a similar form for the treatment of scaphoid fractures for more than 4 years , Calcaneal fractures, corrective osteotomies, and arthrodesis with excellent success in everyday clinical practice. Treatment with an allogenic bone screw is compared with the current standard treatment with resorbable interference screw MectaScrew (composite), Medacta Int. Str. Regina 34, 6874 Castel San Pietro, Switzerland) in a control group. The aim is to include 80 patients who will be included in the study, i.e. 40 per group. Surgical method, treatment plan and follow up treatment do not differ.

The main objective of the planned study is to analyze the dilation of the bone tunnels in the two groups. This will be done by means of magnetic resonance imaging (MRI) and computer tomography (CT) examinations (MRI preoperatively, postoperatively (within 3 days) and at 6, 12 and 24 months after surgery, CT postoperatively within 3 days and at 6 and 24 months after surgery). The bone tunnels are measured and the results of the two groups are compared to determine whether the allograft screw shows less bone tunnel dilation than the current standard treatment. An initial evaluation of the data and publication is planned after 12 months; the final evaluation and publication will take place after 24 months. The secondary objectives are to record the advantages and disadvantages of the allografts and to analyze their safety and effectiveness. In particular, the incorporation of the screws is to be assessed and classified. In order to better assess the outcome of the operation, clinical parameters will be recorded, and the two groups compared with each other. Furthermore, MRI will be analyzed for its informative value with regard to bone tunnel measurement.

The null hypothesis is that the two surgical procedures (bone screw / biocomposite screw) do not differ in outcome. The alternative hypothesis is that the use of the human, allogenic cortical bone screw as a fixation element for anterior cruciate ligament reconstruction results in faster and, above all, better incorporation of the graft, with less widening of the bone tunnel. Based on the experience of the investigators with similar osteosynthesis material made from allogenic bone, it is to be expected that the bone tunnel will heal scare free. The investigators see the advantage of the proposed treatment particularly in its bone-sparing nature. It is to be expected that this will make possible revision easier and that a two-stage procedure will be necessary less often.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: bone tunnel widening will be measured by CT and/or MRI and measured in mm
timeFrame: immadiately after surgery, 3, 6, 12 and 24 months after surgery.
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) Scores
timeFrame: before surgery and 6, 12 and 24 months after surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores
timeFrame: before surgery and 6, 12 and 24 months after surgery
measure: Lysholm Knee Score
timeFrame: before surgery and 6, 12 and 24 months after surgery
measure: Tegner Activity Score
timeFrame: before surgery and 6, 12 and 24 months after surgery
Other outcomes:
Locations:
city: Schwaz
country: Austria
facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H.
state: Tirol
city: Schwaz
country: Austria
facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
state: Tirol
Study officials:
affiliation: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
name: Alexander Rofner-Moretti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hapa O, Barber FA. ACL fixation devices. Sports Med Arthrosc Rev. 2009 Dec;17(4):217-23. doi: 10.1097/JSA.0b013e3181bf668c.
citation: 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.
citation: 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.
citation: 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.