Clinical and Radiologic Outcome of First Metatarsophalangeal Joint Arthrodesis Using a Human Allogeneic Cortical Bone Screw.
Beatrice Hanslik-Schnabel, Daniel Flöry, Gudrun H Borchert...
https://pubmed.ncbi.nlm.nih.gov/35924004Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06357091
ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
Led by Alexander Rofner-Moretti · Updated on 2026-01-21
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies adults with anterior cruciate ligament (ACL) rupture who need reconstructive surgery. It compares two types of screws used for fixing the graft during ACL reconstruction: a human allogeneic cortical bone screw called Shark Screw ACL and a conventional biocomposite screw (Mecta). The goal is to see if the bone screw reduces bone tunnel widening and lowers the rate of graft re-rupture. Knee function scores before and after surgery are also recorded to assess outcomes. Participants undergo ACL reconstruction with either the allogeneic bone screw or the biocomposite screw. The surgical technique is the same for both groups, including arthroscopic confirmation of diagnosis, tendon preparation, bone tunnel creation, graft insertion, and fixation with the assigned interference screw. The tibial bone tunnel is filled with cancellous chips, and graft stability is checked before wound closure. Participants have MRIs before surgery, within 3 days after surgery, and at 6, 12, and 24 months post-surgery. CT scans are done immediately after surgery, and at 6 and 24 months. Knee scores (IKDC, KOOS, Lysholm, Tegner) are collected before surgery and at 6, 12, and 24 months. The study measures bone tunnel widening in millimeters over time and evaluates graft incorporation, safety, and knee function. Total participation lasts 24 months after surgery.
CONDITIONS
Brief Title
ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- MRI-verified rupture of the anterior cruciate ligament
- Indication for replacement surgery
- Surgery within 6 months of injury
- Uninjured contralateral knee
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate recovery period
Participants undergo arthroscopic anterior cruciate ligament reconstruction using either the Shark Screw ACL® or a biocomposite interference screw. The surgery includes creation of bone tunnels, graft fixation with the assigned screw, and filling of the tibial bone tunnel with cancellous chips.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 24 months
Participants are monitored with clinical assessments and imaging to evaluate bone tunnel widening and graft incorporation after surgery.
MRI and CT scans immediately post-surgery (within 3 days), and at 3, 6, 12, and 24 months post-surgery; clinical score assessments before surgery and at 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
Schwaz, Tyrol, Austria, 6130
Actively Recruiting
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Research Team
A
Alexander Rofner-Moretti, MD
M
Markus Reichkendler, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A human, allogeneic cortical bone screw for distal interphalangeal joint (DIP) arthrodesis: a retrospective cohort study with at least 10 months follow-up.
Christian Krasny, Christian Radda, Ralf Polke...
https://pubmed.ncbi.nlm.nih.gov/36757467Treatment of scaphoid fractures and pseudarthroses with the human allogeneic cortical bone screw. A multicentric retrospective study.
Simon Sailer, Simon Lechner, Andreas Floßmann...
https://pubmed.ncbi.nlm.nih.gov/36765020The application of an allogeneic bone screw for osteosynthesis in hand and foot surgery: a case series.
Klaus Pastl, Wolfgang Schimetta
https://pubmed.ncbi.nlm.nih.gov/33834287Incorporation of an Allogenic Cortical Bone Graft Following Arthrodesis of the First Metatarsophalangeal Joint in a Patient with Hallux Rigidus.
Iva Brcic, Klaus Pastl, Harald Plank...
https://pubmed.ncbi.nlm.nih.gov/34073841Arthrodesis and Defect Bridging of the Upper Ankle Joint with Allograft Bone Chips and Allograft Cortical Bone Screws (Shark Screw®) after Removal of the Salto-Prosthesis in a Multimorbidity Patient: A Case Report.
Klaus Pastl, Eva Pastl, Daniel Flöry...
https://pubmed.ncbi.nlm.nih.gov/35888116ACL reconstruction with adjustable-length loop cortical button fixation results in less tibial tunnel widening compared with interference screw fixation.
Raul Mayr, Vinzenz Smekal, Christian Koidl...
https://pubmed.ncbi.nlm.nih.gov/31372680Outcomes after arthroscopic revision surgery for anterior cruciate ligament injuries.
Alexei V Yumashev, Tatyana V Baltina, Dmitrii V Babaskin
https://pubmed.ncbi.nlm.nih.gov/33739222Bone tunnel enlargement following anterior cruciate ligament reconstruction: a randomised comparison of hamstring and patellar tendon grafts with 2-year follow-up.
K E Webster, J A Feller, K A Hameister
https://pubmed.ncbi.nlm.nih.gov/11354858Achilles tendon allograft reconstruction of the anterior cruciate ligament-deficient knee.
R M Linn, D A Fischer, J P Smith...
https://pubmed.ncbi.nlm.nih.gov/8291633