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Completed

NCT Number: NCT07555782

Shear-Wave Elastography of Regenerated Hamstring Tendons After ACL Reconstruction (SWE-ACL)

Anterior cruciate ligament (ACL) reconstruction using autologous hamstring tendon grafts is a commonly performed procedure. Although the semitendinosus and gracilis tendons demonstrate regeneration at the donor site, the structural and biomechanical properties of the regenerated tissue may differ from native tendon, potentially affecting muscle function.

This study aims to quantitatively assess the elasticity of regenerated hamstring tendons using shear-wave elastography (SWE) and to compare these measurements with the contralateral intact side. Additionally, the relationship between tendon elasticity and isokinetic hamstring muscle strength will be evaluated. Secondary objectives include investigating the association between elastography findings and functional clinical outcomes, as well as the effect of postoperative time and patient-related factors such as age and body mass index.

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Key information

About this study

Anterior cruciate ligament reconstruction with autologous hamstring tendon grafts, typically using the semitendinosus and gracilis tendons, is widely used in orthopedic practice. Following graft harvesting, these tendons may regenerate over time; however, the regenerated tissue often demonstrates altered histological and biomechanical characteristics, including disorganized collagen structure and reduced type I collagen content. These changes may lead to decreased tendon elasticity and impaired force transmission, potentially contributing to deficits in muscle strength and functional performance.

Shear-wave elastography (SWE) is a non-invasive imaging modality that enables quantitative assessment of tissue stiffness by measuring elastic modulus or shear-wave velocity. This technique has increasingly been used to evaluate musculoskeletal tissues and may provide objective insight into tendon regeneration quality. Isokinetic dynamometry, on the other hand, allows precise measurement of muscle strength at different angular velocities and is widely used in functional assessment after ACL reconstruction.

The primary objective of this study is to evaluate the elasticity of regenerated semitendinosus and gracilis tendons using SWE in patients who have undergone ACL reconstruction with hamstring autografts. Elastography measurements will be compared with those obtained from the contralateral intact side. Furthermore, the association between tendon elasticity and isokinetic hamstring muscle strength will be analyzed.

Secondary objectives include examining the relationship between elastography findings and functional clinical scores, including the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores, as well as functional performance tests. The effect of postoperative duration will also be assessed by comparing early (6-12 months) and late (>12 months) postoperative periods. In addition, the influence of demographic factors such as age and body mass index on tendon elasticity and muscle strength will be evaluated.

This study is designed as a prospective cross-sectional observational study. Patients who have undergone ACL reconstruction with autologous hamstring grafts and have completed at least 6 months of postoperative follow-up will be included. Participants will undergo shear-wave elastography assessment of the hamstring tendons. Previously obtained magnetic resonance imaging (MRI) and isokinetic muscle strength (Cybex) data will be collected from institutional records. MRI will be evaluated for graft signal characteristics, tunnel position, and graft thickness, while isokinetic testing will provide quantitative measurements of hamstring strength at different angular velocities.

All data will be analyzed to determine correlations between tendon elasticity, muscle strength, imaging findings, and clinical outcomes. The findings of this study are expected to improve understanding of tendon regeneration following ACL reconstruction and may contribute to more individualized rehabilitation strategies and postoperative assessment using non-invasive biomarkers such as SWE.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have undergone anterior cruciate ligament (ACL) reconstruction using autologous hamstring tendon grafts (semitendinosus and gracilis)
  • At least 6 months of postoperative follow-up
  • Availability of postoperative magnetic resonance imaging (MRI) and isokinetic muscle strength (Cybex) measurements
  • Willingness to participate and provide informed consent

Exclusion criteria

  • History of previous surgery on the same lower extremity (other than the index ACL reconstruction)
  • Presence of neuromuscular disorders affecting lower extremity function
  • Incomplete clinical, imaging, or functional data
  • Inability to undergo elastography assessment

Treatment and study plan

Shear-Wave Elastography Assessment

Other

Shear-Wave elastography (SWE) will be used to quantitatively assess the elasticity of regenerated hamstring tendons. Measurement will be obtained in kilopascal (kPa) or meters per second (m/s) and compared with the contralateral intact side. These values will be analyzed in relation to isokinetic muscle strength and clinical outcomes.

Other names: SWE, Elastography

Primary outcomes

  1. Elasticity of Regenerated Hamstring Tendons Measured by Shear-Wave Elastography

    Time frame: At a single postoperative assessment (≥6 months after surgery)

    Quantitative assessment of the elasticity of regenerated semitendinosus and gracilis tendons using shear-wave elastography (SWE). Elasticity will be measured as Young's modulus (kilopascals, kPa) or shear-wave velocity (meters per second, m/s). Measurements will be obtained from the operated limb and compared with the contralateral intact side.

Secondary outcomes

  1. Isokinetic Hamstring Muscle Strength

    Time frame: At a single postoperative assessment (≥6 months after surgery)

    Assessment of hamstring muscle strength using an isokinetic dynamometer (Cybex). Peak torque (Nm/kg) will be measured at angular velocities of 60°/s and 180°/s during concentric and eccentric contractions.

  2. International Knee Documentation Committee (IKDC) Score

    Time frame: At a single postoperative assessment (≥6 months after surgery)

    Patient-reported knee function assessed using the IKDC subjective knee evaluation form. Scores range from 0 to 100, with higher scores indicating better function.

  3. Lysholm Knee Score

    Time frame: At a single postoperative assessment (≥6 months after surgery)

    Functional knee status assessed using the Lysholm scoring system. Scores range from 0 to 100, with higher scores indicating better function.

  4. Tegner Activity Scale

    Time frame: At a single postoperative assessment (≥6 months after surgery)

    Activity level assessed using the Tegner scale, ranging from 0 (sick leave or disability) to 10 (competitive sports at elite level).

  5. Graft Characteristics on MRI

    Time frame: MRI obtained during postoperative follow-up (≥6 months)

    Evaluation of graft characteristics on MRI, including signal intensity using a grading-based evaluation method.

  6. Femoral and Tibial Tunnel Position on MRI

    Time frame: MRI obtained during postoperative follow-up (≥6 months after surgery)

    Postoperative femoral and tibial tunnel position assessed on MRI using descriptive anatomic localization and position measurements.

  7. ACL Graft Thickness on MRI

    Time frame: MRI obtained during postoperative follow-up (≥6 months after surgery)

    Postoperative ACL graft thickness measured on MRI in millimeters.

  8. Postoperative Duration Group Comparison

    Time frame: At a single postoperative assessment (6 and 12 months after surgery)

    Comparison of tendon elasticity and muscle strength between early (6-12 months) and late (>12 months) postoperative groups.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

Quantitative Assessment of Regenerated Hamstring Tendon Elasticity Using Shear-Wave Elastography and Its Relationship With Isokinetic Muscle Strength and Clinical Outcomes After Anterior Cruciate Ligament Reconstruction

Acronym: SWE-ACL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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