Anterior Cruciate Ligament RuptureNCT06357091
ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
A study testing ACL reconstruction with Shark Screw ACL® and ACL reconstruction with biocomposite screw (Mecta) in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Reconstruction, run by Alexander Rofner-Moretti at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injury
- What is being tested?
- ACL reconstruction with Shark Screw ACL® and ACL reconstruction with biocomposite screw (Mecta)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 16 Feb 2026to 31 Jan 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRI-verified rupture of the anterior cruciate ligament
- Indication for replacement surgery
- Surgery within 6 months of injury
- Uninjured contralateral knee
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
Schwaz, Tyrol, 6130
Alexander Rofner-Moretti, MD, +435242600, alexander.rofner-moretti@kh-schwaz.at
Markus Reichkendler, MD, +435242600, markus.reichkendler@kh-schwaz.at
About this study
Official title: ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
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
Read the 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 \>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.
- Conditions
- Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injury
- Being tested
- ACL reconstruction with Shark Screw ACL®, ACL reconstruction with biocomposite screw (Mecta)
- 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)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction with Shark Screw ACL®Procedure or surgery
ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening
ACL reconstruction with biocomposite screw (Mecta)Procedure or surgery
ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ACL reconstruction with biocomposite screw (Mecta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immadiately after surgery, 3, 6, 12 and 24 months after surgery.
Secondary outcomes (4)
International Knee Documentation Committee (IKDC) Scores
IKDC will be evaluated by questionnaires, it can be between 0 and 100 the higher the better is the outcome
Measured: before surgery and 6, 12 and 24 months after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores
KOOS Score will be evaluated by questionnaires, it can be between 0 and 100 the higher the better is the outcome
Measured: before surgery and 6, 12 and 24 months after surgery
Lysholm Knee Score
Lysholm Knee Score will be evaluated by questionnaires, one of the most frequently used assessment tools for the results of Anterior cruciate ligament reconstruction even though it only measures activities of daily living, it can be between 0 and 100 the higher the better is the outcome.
Measured: before surgery and 6, 12 and 24 months after surgery
Tegner Activity Score
Tegner Activity Score will be evaluated by questionnaires
Measured: before surgery and 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start16 Feb 2026 (estimated)
- Primary completion31 Jan 2034 (estimated)
- Study completion31 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Rofner-Moretti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Rofner-Moretti, Bezirkskrankenhaus Schwaz
- Investigators
- Alexander Rofner-Moretti, MD, Principal investigator, Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357091
- Sponsor's protocol ID
- 1097/2023 ACL-Shark Screw®
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to sensitivity of individual data and data protection restrictions in Austria
Publications
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.
PubMed 35924004Krasny 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.
PubMed 36757467Sailer 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.
PubMed 36765020Pastl 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.
PubMed 33834287Brcic 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.
PubMed 34073841Pastl 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.
PubMed 35888116Mayr 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.
PubMed 31372680Yumashev 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.
PubMed 33739222Webster 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.
PubMed 11354858Linn 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.
PubMed 8291633Fahey 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.
PubMed 8037283Taketomi 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.
PubMed 36254269Fauno 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.
PubMed 16325084Lee 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.
PubMed 34708137Moon 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.
PubMed 33887417
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06357091
- Acronym / sponsor ID
- 1097/2023 ACL-Shark Screw®
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexander Rofner-MorettiUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2034 (estimated)
- Study completion
- 31 Jan 2034 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \>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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®) | Experimental | Procedure: ACL reconstruction with Shark Screw ACL®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. |
| ACL reconstruction with Mecta Composite interference screw | Active comparator | Procedure: ACL reconstruction with biocomposite screw (Mecta)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MRI-verified rupture of the anterior cruciate ligament
- Indication for replacement surgery
- Surgery within 6 months of injury
- Uninjured contralateral knee
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstruction with Shark Screw ACL®ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening | Procedure or surgery | ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®) |
| ACL reconstruction with biocomposite screw (Mecta)ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening | Procedure or surgery | ACL reconstruction with Mecta Composite interference screw |
Primary outcome
bone tunnel widening will be measured by CT and/or MRI and measured in mm
Time frame: immadiately after surgery, 3, 6, 12 and 24 months after surgery.
bone tunnel widening will be evaluated and measured by CT and/or MRI and measured in mm
4 secondary outcomes
International Knee Documentation Committee (IKDC) Scores
Time frame: before surgery and 6, 12 and 24 months after surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores
Time frame: before surgery and 6, 12 and 24 months after surgery
Lysholm Knee Score
Time frame: before surgery and 6, 12 and 24 months after surgery
Tegner Activity Score
Time frame: before surgery and 6, 12 and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 35924004Hanslik-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.
- Background: PubMed 36757467Krasny 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.
- Background: PubMed 36765020Sailer 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.
- Background: PubMed 33834287Pastl 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.
- Background: PubMed 34073841Brcic 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.
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- Individual participant dataSharing planned: No. due to sensitivity of individual data and data protection restrictions in Austria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Rofner-Moretti, MD principal investigator
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction with Shark Screw ACL® and ACL reconstruction with biocomposite screw (Mecta) in people with Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Reconstruction, run by Alexander Rofner-Moretti at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rofner-Moretti, MD (+435242600, alexander.rofner-moretti@kh-schwaz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone tunnel widening will be measured by CT and/or MRI and measured in mm (time frame: immadiately after surgery, 3, 6, 12 and 24 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357091, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.