SharkScrew ACL RCT

NCT07830953 · tracked via the Priya Life Science Austria tracker

Sponsor

Austrian Workers Compensation Board Styria

Phase

Not applicable

Started

2026-11-01

Last updated

2026-09-21

Condition(s) studied

ACL - Anterior Cruciate Ligament Rupture

Investigational drug(s) / intervention(s)

ACL Reconstruction with a Biocomposite ScrewACL Reconstruction using a PEEK ScrewACL Reconstruction using an Allograft Screw

ACL Reconstruction with a Biocomposite Screw: ACL Reconstruction using a standardized technique. Tibial Fixation using a Biocomposite Screw.

ACL Reconstruction using a PEEK Screw: ACL Reconstruction using a standardized technique. Tibial Fixation using a PEEK Screw.

ACL Reconstruction using an Allograft Screw: ACL Reconstruction using a standardized technique. Tibial Fixation using a SharkScrew Allograft Interference Screw.

Study summary

This prospective, randomized controlled trial will compare three tibial interference screw types used for graft fixation during primary anterior cruciate ligament (ACL) reconstruction: a polyetheretherketone (PEEK) screw, a biocomposite screw, and an allograft bone screw. Although interference screws are widely used for tibial fixation, the optimal screw material remains uncertain, particularly regarding its effect on tibial tunnel widening and graft incorporation.

Adult patients undergoing primary ACL reconstruction with a quadriceps tendon autograft using a standardized surgical technique will be randomly assigned to one of the three tibial fixation methods. The primary outcome is tibial tunnel widening measured by computed tomography (CT) 12 months after surgery. Secondary outcomes include graft integration assessed by magnetic resonance imaging (MRI) and patient-reported clinical outcomes, including the Lysholm, Tegner, KOOS, and ACL-Return to Sport after Injury (ACL-RSI) scores, collected during routine follow-up. The study aims to determine whether allograft bone screws reduce tunnel widening and improve graft integration compared with PEEK and biocomposite screws while maintaining comparable clinical outcomes.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Male and non-pregnant female patients aged 18-70 years * MRI-confirmed rupture of the anterior cruciate ligament (ACL) * Clinically positive anterior drawer test and Lachman test * Subjective instability * Clinically and MRI-confirmed intact posterior cruciate ligament (PCL), medial collateral ligament (MCL), and posterolateral corner * Written informed consent obtained * Patient is able and willing to participate in the study Exclusion Criteria: * Previous surgery on the affected knee joint (ACL reconstruction, fracture fixation, osteotomy, or partial joint replacement) * Body mass index (BMI) \> 40 * Coronal instability due to injury of the medial collateral ligament or posterolateral corner * Meniscal injury requiring postoperative restriction of weight-bearing (e.g., root tears, radial tears) * The patient is unable to speak German * The patient is pregnant

Primary outcome measure(s)

Tibial Tunnel Widening — 1 Year Postop
CT Measurement of the tibial Tunnel Widening in mm. The difference will be calculated between drilled diameter and measured diameter.

Trial sites (1)

Facility	City	Region	Status
AUVA UKH Steiermark, Standort Graz	Graz	Styria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07830953 on ClinicalTrials.gov ↗ ← All trials in Austria