Comparison of Tendon and Muscle-Tendon Semitendinosus Grafts After ACL Reconstruction

NCT07404046 | Recruiting

• 1 other identifier: 2024/0719-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Comparison of tendon to bone ingrowth in bone tunnels and intra-articular remodeling of the graft after anterior cruciate ligament surgery with a muscle-tendon graft and those with a tendon graft. Subjects and methods: It is a single-blind prospective randomized study that would include at least 40 patients with an anterior cruciate ligament rupture. Patients would be randomly divided into two groups of minimally 20 patients each. Patients in the first study group would undergo ACL reconstruction with a muscle-tendon graft, while patients in the control group would be treated with the standard method of ACL reconstruction with a tendon graft. Expected contribution to the field: The assumption is that the obtained results could enable a better understanding of the contribution of remaining muscle fibers on the tendon in anterior cruciate ligament reconstruction operations to the tendon to bone ingrowth and intra-articular remodeling of the graft of operated patients.

Conditions

Cruciate Ligament Reconstruction

Keywords

Arthroscopy; Tissue Remodeling; Anterior Cruciate Ligament; Semitendinosus Muscle; Knee

Outcome Measures

Primary Outcomes (1)

• SNQ

  To analyze and compare T2 signal-to-noise ratio values on magnetic resonance imaging at 6 weeks, 6 and 12 months postoperatively within and between the two study groups. The SNQ is calculated as the ratio of the graft T2 signal intensity to the signal intensity of a reference tissue on MRI. Higher SNQ values indicate higher graft signal, which corresponds to lower graft maturity/quality. Scale: Continuous numerical value (exact values depend on MRI signal calibration).

  6 weeks, 6 and 12 months postoperatively

Secondary Outcomes (9)

• Bone Tunnel Diameter - Femur

  6 weeks, 6 months, 12 months postoperatively

• Bone Tunnel Diameter - Tibia

  6 weeks, 6 months, 12 months postoperatively

• Knee Stability - Anterior Tibial Translation

  12 months postoperatively

• KOOS - Pain Subscale

  Before surgery, 6 weeks, 6 months, 12 months postoperatively

• KOOS - Symptoms Subscale

  Before surgery, 6 weeks, 6 months, 12 months postoperatively

Study Arms (4)

Tendon

ACTIVE COMPARATOR

Intervention Name: Tendon-only ST graft Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus tendon graft without meniscus repair. Details: Standard tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Anesthesia per protocol Standardized post-op rehab

Procedure: ACL reconstruction

Tendon + meniscus

ACTIVE COMPARATOR

Intervention Name: Tendon-only ST graft + meniscus repair Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus tendon graft with concurrent meniscus suture. Details: Standard tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Meniscus repair as needed Anesthesia per protocol Standardized post-op rehab

Procedure: ACL reconstruction

Muscle tendon

ACTIVE COMPARATOR

Intervention Name: Muscle-tendon ST graft Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus graft preserving muscle fibers, without meniscus repair. Details: Muscle-tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Anesthesia per protocol Standardized post-op rehab

Procedure: ACL reconstruction

Muscle tendon + meniscus

ACTIVE COMPARATOR

Intervention Name: Muscle-tendon ST graft + meniscus repair Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus graft preserving muscle fibers, with meniscus repair. Details: Muscle-tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Meniscus repair technique as needed Anesthesia per protocol Standardized post-op rehab

Procedure: ACL reconstruction

Interventions

ACL reconstruction PROCEDURE

Participants will undergo arthroscopic all-inside anterior cruciate ligament reconstruction using an autologous semitendinosus graft. In the experimental intervention, a muscle-tendon semitendinosus graft is used, with preservation of muscle fibers on the tendon. In the control intervention, a standard tendon-only semitendinosus graft is used. In both groups, graft preparation, tunnel creation, fixation technique, and concomitant lateral tenodesis are identical, and all procedures are performed by the same surgeon following a standardized protocol.

Muscle tendon; Muscle tendon + meniscus; Tendon; Tendon + meniscus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University hospital Dubrava

Zagreb, 10000, Croatia

RECRUITING

Central Study Contacts

Marin Glavčić, MD

CONTACT

+385 1 290 2571; mglavcic@kbd.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CR (1)