Tendon-only versus muscle-and-tendon semitendinosus grafts for ACL reconstruction
Comparison of Bone Ingrowth and Intra-articular Remodeling of Autologous Tendon and Muscle-tendon Semitendinosus Graft After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
This trial will test whether keeping muscle fibers on the semitendinosus graft leads to better tendon-to-bone healing and graft remodeling than a tendon-only graft in adults 18–50 having ACL reconstruction with lateral tenodesis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital Dubrava Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07404046 on ClinicalTrials.gov |
What this trial studies
This is a single-blind, randomized study enrolling at least 40 adults (18–50) with MRI-confirmed ACL rupture who require concomitant lateral tenodesis. Participants are randomized 1:1 to arthroscopic all-inside ACL reconstruction using either a muscle-tendon semitendinosus graft or a standard tendon-only semitendinosus graft, with all surgeries performed by the same surgeon and supplemented by modified Lemaire lateral tenodesis. Outcomes include MRI-based measures of graft remodeling and tendon-to-bone healing using proton density sequences and T2 mapping (signal-to-noise quotient), patient-reported outcomes (EQ-5D, KOOS, Croatian IKDC), and objective knee stability by digital Lachmeter up to 12 months. Clinical assessments and MRIs are scheduled at baseline, 6 weeks, 6 months, and 12 months to compare structural and functional recovery between groups.
Who should consider this trial
Good fit: Adults aged 18–50 with clinically and MRI-confirmed ACL rupture, intact posterior cruciate and collateral ligaments, and an indication for concomitant lateral tenodesis (for example young age, positive pivot-shift, Segond fracture, pivoting sports, or high joint laxity) are ideal candidates.
Not a fit: Patients with prior ACL reconstruction on the same knee, inability to use a quadruple semitendinosus graft or graft diameter under 7.5 mm, unresolved meniscal repair failure, or current/previous joint infection are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could improve graft incorporation and knee stability after ACL surgery, potentially reducing re-injury risk and improving recovery.
How similar studies have performed: Some biomechanical and observational work suggests remaining muscle fibers can affect graft healing, but randomized clinical comparisons of muscle-tendon versus tendon-only semitendinosus grafts are limited, so this approach is relatively novel in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically and radiologically confirmed anterior cruciate ligament (ACL) rupture. * Age between 18 and 50 years. * Intact posterior cruciate ligament and collateral ligaments. * Signed informed consent to participate in the study. * Patients meeting at least one indication for concomitant lateral tenodesis, including: age under 25 years, positive pivot-shift test, presence of Segond fracture, participation in sports with frequent changes of direction and rotational knee loads, or joint hypermobility (Beighton score ≥ 7). Exclusion Criteria: * Previous ACL reconstruction of the same knee. * Inability to use a graft prepared by quadruple folding of the semitendinosus tendon. * Graft diameter \< 7.5 mm. * MRI-confirmed unsuccessful meniscal healing after repair. * Acute joint infection or history of joint infection.
Where this trial is running
Zagreb
- University hospital Dubrava — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Marin Glavčić, MD
- Email: mglavcic@kbd.hr
- Phone: +385 1 290 2571
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.