NCT07555782

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Anterior Cruciate Ligament ReconstructionHamstring TendonShear-Wave ElastographyIsokinetic StrengthFunctional Outcomes

Outcome Measures

Primary Outcomes (1)

  • Elasticity of Regenerated Hamstring Tendons Measured by Shear-Wave Elastography

    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.

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

Secondary Outcomes (8)

  • Isokinetic Hamstring Muscle Strength

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

  • International Knee Documentation Committee (IKDC) Score

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

  • Lysholm Knee Score

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

  • Tegner Activity Scale

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

  • Graft Characteristics on MRI

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

  • +3 more secondary outcomes

Study Arms (1)

ACL Reconstruction With Hamstring Autograft

Patients who have undergone anterior cruciate ligament (ACL) reconstruction using autologous hamstring tendon grafts (semitendinosus and gracilis) and have completed at least 6 months of postoperative follow-up will be included. Participants will undergo shear-wave elastography (SWE) assessment of regenerated hamstring tendons. Previously obtained magnetic resonance imaging (MRI) and isokinetic muscle strength (Cybex) measurements will be collected from institutional records. Elastography measurements will be compared with the contralateral intact side, and associations with muscle strength, imaging findings, and functional clinical outcomes will be analyzed.

Other: Shear-Wave Elastography Assessment

Interventions

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.

Also known as: SWE, Elastography
ACL Reconstruction With Hamstring Autograft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients who have undergone anterior cruciate ligament (ACL) reconstruction using autologous hamstring tendon grafts (semitendinosus and gracilis) and have completed at least 6 months of postoperative follow-up. Participants will be selected from a single tertiary referral center and will have available postoperative magnetic resonance imaging (MRI) and isokinetic muscle strength (Cybex) data. All eligible patients will undergo shear-wave elastography (SWE) assessment of the regenerated hamstring tendons at the time of study enrollment.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Ataşehir, Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (4)

  • Alp NB, Akdag G, Kaleli T, Macunluoglu AC, Uzunlulu N. Evaluation of patellar tendon with shear wave elastography after anterior cruciate ligament reconstruction using hamstring tendons. Jt Dis Relat Surg. 2020;31(1):137-42. doi: 10.5606/ehc.2020.71745.

    PMID: 32160507BACKGROUND
  • Pasurka M, Falck T, Kubach J, Simon M, Sollner S, Strobel D, Perl M, Betsch M. Comparison of In Vivo Stiffness of Tendons Commonly Used for Anterior Cruciate Ligament Reconstruction - A Shear Wave Elastography Study. Acad Radiol. 2024 Aug;31(8):3297-3305. doi: 10.1016/j.acra.2024.01.037. Epub 2024 Feb 19.

    PMID: 38378326BACKGROUND
  • Panagopoulos A, Giannatos V, Moros G, Mylonas D, Kouzelis A, Gliatis J. Isokinetic Muscle Strength and Knee Function in Anatomical Anterior Cruciate Ligament Reconstruction With Hamstring Autografts: A Prospective Randomized Comparative Study Between Suspensory and Expandable Femoral Fixation in Male Patients. Cureus. 2022 Dec 13;14(12):e32482. doi: 10.7759/cureus.32482. eCollection 2022 Dec.

    PMID: 36644094BACKGROUND
  • Grasso S, Linklater J, Li Q, Parker DA. Validation of an MRI Protocol for Routine Quantitative Assessment of Tunnel Position in Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2018 Jun;46(7):1624-1631. doi: 10.1177/0363546518758950. Epub 2018 Mar 28.

    PMID: 29589954BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesTendon InjuriesMuscle Weakness

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Orthopedic Surgery Resident, Research Fellow

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start

March 30, 2025

Primary Completion

March 30, 2026

Study Completion

April 30, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared.

Locations