ACL reconstruction using a human cortical bone (Shark Screw®) versus a biocomposite interference screw

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with MRI-confirmed ACL rupture who need reconstructive surgery will receive graft fixation with either a human allogeneic cortical bone screw (Shark Screw®) or a biocomposite interference screw; outcomes will be compared over two years. Tunnel widening will be measured using MRI and CT at specified intervals and re-rupture rates will be recorded. Standard knee outcome questionnaires will be collected before surgery and at 6, 12, and 24 months after surgery. The trial focuses on whether the human cortical bone screw leads to less tunnel dilatation and similar or lower failure rates than the conventional biocomposite screw.

Why it matters

Who can join: the full rules

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)

Where it's running

• Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
  Schwaz, Tyrol, Austria Recruiting

Study contacts

• Principal investigator: Alexander Rofner-Moretti, MD — Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
• Study coordinator: Alexander Rofner-Moretti, MD
• Email: alexander.rofner-moretti@kh-schwaz.at
• Phone: +435242600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Donor ankle sensorimotor recovery after ACL reconstruction with a peroneus longus graft

  This study tests how the donor ankle recovers sensorimotor function after ACL reconstruction using a peroneus longus tendon autograft in adults 18–55.

  Recruiting Gazi University · Çankaya, Ankara · NCT07762989

• Quadriceps tendon vs peroneus longus tendon grafts for ACL reconstruction

  This randomized trial tests whether using a quadriceps tendon autograft works as well as a peroneus longus tendon autograft for ACL reconstruction in adults, looking at knee function and donor-site effects.

  Recruiting Acibadem University · Istanbul, Besiktas · NCT07671729

• Correlation between where the knee tunnels are placed during ACL reconstruction and how well the knee heals

  This study tests whether the position of the femoral and tibial tunnels during ACL reconstruction relates to how well patients recover.

  Recruiting at 2 sites Sakarya University · Sakarya and 1 other locations · NCT07876635

• Analgesic effects of adding BiFeS block to adductor canal block after ACL reconstruction

  This study tests whether adding a BiFeS block to the standard adductor canal block provides better pain relief after ACL reconstruction.

  Recruiting Ankara Etlik City Hospital · Ankara · NCT07859397

• Neuromuscular Profiles After ACL Reconstruction

  This study tests how quadriceps and hamstring strength and muscle activation patterns look 4–12 months after ACL reconstruction to see if distinct neuromuscular profiles emerge.

  Recruiting Hopitaux de Saint-Maurice · Saint-Maurice, Demande · NCT07792863

• Bone-patellar tendon–bone graft versus patellar tendon graft for ACL reconstruction

  This randomized comparison tests whether a patellar tendon graft without the patellar bone plug reduces donor-site problems and gives similar knee function to the standard bone–patellar tendon–bone graft in athletes undergoing ACL reconstruction.

  Recruiting Universidad de Granada · Granada, Granada · NCT07475351

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.