Which screw keeps the knee tunnel from widening after ACL surgery?
NCT ID NCT07830953
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers compare three tibial interference screws used to fix the graft during ACL reconstruction: a PEEK screw, a biocomposite screw, and an allograft bone screw. Adults having primary ACL reconstruction with a quadriceps tendon graft are randomly assigned to one screw type. The trial measures tibial tunnel widening on CT scans 12 months after surgery and checks graft healing on MRI plus patient-reported knee scores. The goal is to learn which screw material best limits tunnel widening and supports graft integration.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- three types of tibial interference screws used to fix the ACL graft: a PEEK screw, a biocomposite screw, and an allograft bone screw
- What this could lead to
- If one screw type limits tunnel widening and helps the graft integrate better, surgeons could choose it to improve knee stability and recovery after ACL reconstruction.
- What could go wrong
- The trial is small, with 33 participants, and compares only three screw types in one surgical technique. Differences in tunnel widening or graft healing may be too small to detect, and results may not apply to other grafts or surgeons.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AUVA UKH Steiermark, Standort Graz
Graz, Styria, 8044, Austria
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Other studies related to the condition(s) this trial covers.
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