ACL reconstruction using a human cortical bone (Shark Screw®) versus a biocomposite interference screw
ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
This trial will test whether using a human cortical bone screw (Shark Screw®) instead of a biocomposite interference screw reduces tunnel widening and keeps re-rupture rates low for people having ACL reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bezirkskrankenhaus Schwaz Academic / other |
| Locations | 1 site (Schwaz, Tyrol) |
| Trial ID | NCT06357091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with an MRI-confirmed ACL rupture who are indicated for reconstruction within six months of injury and have an uninjured contralateral knee.
Not a fit: Patients with a prior ACL rupture on the same knee, primary bone disease, inflammatory disease, unstable meniscus, complete collateral ligament rupture, or early rerupture during follow-up are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the human cortical bone screw could reduce tunnel widening and potentially lower re-rupture risk, which may preserve bone stock and simplify any future revision surgery.
How similar studies have performed: Conventional interference-screw fixation is well established, but comparative evidence for human allogeneic cortical bone screws is limited, so this is a relatively novel comparative approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Schwaz, Tyrol
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.