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NCT06664047
Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
NA trial testing OTT ACLR in Anterior Cruciate Ligament Rupture in 150 participants. Currently enrolling.
1 November 2028
Quick facts
| Lead sponsor | Ankara City Hospital Bilkent |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 24 October 2024 |
| Primary completion | 1 November 2028 |
| Estimated completion | 1 November 2028 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- OTT ACLR
- ACLR LET
Conditions studied
- Anterior Cruciate Ligament Rupture — all drugs for Anterior Cruciate Ligament Rupture →
- Anterior Cruciate Ligament Injuries — all drugs for Anterior Cruciate Ligament Injuries →
- Anterior Cruciate Ligament Tear — all drugs for Anterior Cruciate Ligament Tear →
Sponsor
Ankara City Hospital Bilkent
Who can join
Adults 18 to 50, any sex, with Anterior Cruciate Ligament Rupture or Anterior Cruciate Ligament Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. The over-the-top ACL-R technique, which involves routing the graft over the posterior aspect of the lateral femoral condyle, is known for its simplicity and ability to preserve the anatomical footprint of the ACL. Although a non-anatomical reconstruction, the OTT technique has shown comparable clinical results and good return to sports (RTS) ratios when compared to the conventional ACLR alone. It is also favored in revision surgeries or when there is difficulty accessing the femoral tunnel through conventional approaches. However, concerns regarding its ability to fully restore rotational stability persist, especially in high-demand athletes. In contrast, the anteromedial portal technique for ACL-R, combined with LET, has gained popularity due to its effectiveness in controlling both anterior tibial translation and rotational instability. LET augments the intra-articular reconstruction by providing additional restraint against pivot shifts, which can be critical in patients with high-risk profiles for re-injury, such as those participating in pivoting sports. Comparing these two approaches in terms of clinical outcomes, graft integrity, rotational control, and return-to-sport rates with a prospectively randomized controlled trial will help clarify their roles in contemporary ACL surgery and could guide surgeons in choosing the most appropriate method based on patient-specific factors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06664047
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Currently open trials in the same condition.
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Other Ankara City Hospital Bilkent trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06664047 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara City Hospital Bilkent
- Last refreshed: 31 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06664047.
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