Anterior Cruciate Ligament RuptureSWE-ACLNCT07555782
Shear-Wave Elastography of Regenerated Hamstring Tendons After ACL Reconstruction (SWE-ACL)
An observational study of Anterior Cruciate Ligament Rupture and Tendon Injuries, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Tendon Injuries, Muscle Weakness
- What is being tested?
- Shear-Wave Elastography Assessment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Ataşehir, Istanbul, 34752
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Shear-Wave Elastography Assessment
- Keywords
- Anterior Cruciate Ligament Reconstruction, Hamstring Tendon, Shear-Wave Elastography, Isokinetic Strength, Functional Outcomes
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Tendon Injuries, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear-Wave Elastography AssessmentOther
Also called SWE, Elastography
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shear-Wave Elastography Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At a single postoperative assessment (≥6 months after surgery)
Secondary outcomes (8)
Isokinetic Hamstring Muscle Strength
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.
Measured: At a single postoperative assessment (≥6 months after surgery)
International Knee Documentation Committee (IKDC) Score
Patient-reported knee function assessed using the IKDC subjective knee evaluation form. Scores range from 0 to 100, with higher scores indicating better function.
Measured: At a single postoperative assessment (≥6 months after surgery)
Lysholm Knee Score
Functional knee status assessed using the Lysholm scoring system. Scores range from 0 to 100, with higher scores indicating better function.
Measured: At a single postoperative assessment (≥6 months after surgery)
Tegner Activity Scale
Activity level assessed using the Tegner scale, ranging from 0 (sick leave or disability) to 10 (competitive sports at elite level).
Measured: At a single postoperative assessment (≥6 months after surgery)
Graft Characteristics on MRI
Evaluation of graft characteristics on MRI, including signal intensity using a grading-based evaluation method.
Measured: MRI obtained during postoperative follow-up (≥6 months)
Femoral and Tibial Tunnel Position on MRI
Postoperative femoral and tibial tunnel position assessed on MRI using descriptive anatomic localization and position measurements.
Measured: MRI obtained during postoperative follow-up (≥6 months after surgery)
ACL Graft Thickness on MRI
Postoperative ACL graft thickness measured on MRI in millimeters.
Measured: MRI obtained during postoperative follow-up (≥6 months after surgery)
Postoperative Duration Group Comparison
Comparison of tendon elasticity and muscle strength between early (6-12 months) and late (>12 months) postoperative groups.
Measured: At a single postoperative assessment (6 and 12 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Mar 2025
- Primary completion30 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Yavuz, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555782
- Sponsor's protocol ID
- SWE-ACL-2026
- Acronym
- SWE-ACL
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Publications
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.
PubMed 32160507Pasurka 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.
PubMed 38378326Panagopoulos 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.
PubMed 36644094Grasso 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.
PubMed 29589954
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07555782
- Acronym / sponsor ID
- SWE-ACL / SWE-ACL-2026
- Keywords
- Anterior Cruciate Ligament Reconstruction, Hamstring Tendon, Shear-Wave Elastography, Isokinetic Strength, Functional Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL Reconstruction With Hamstring Autograft | – | Other: Shear-Wave Elastography AssessmentPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear-Wave Elastography AssessmentAlso: SWE, ElastographyShear-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 | ACL Reconstruction With Hamstring Autograft |
Primary outcome
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.
8 secondary outcomes
Isokinetic Hamstring Muscle Strength
Time frame: At a single postoperative assessment (≥6 months after surgery)
International Knee Documentation Committee (IKDC) Score
Time frame: At a single postoperative assessment (≥6 months after surgery)
Lysholm Knee Score
Time frame: At a single postoperative assessment (≥6 months after surgery)
Tegner Activity Scale
Time frame: At a single postoperative assessment (≥6 months after surgery)
Graft Characteristics on MRI
Time frame: MRI obtained during postoperative follow-up (≥6 months)
Femoral and Tibial Tunnel Position on MRI
Time frame: MRI obtained during postoperative follow-up (≥6 months after surgery)
ACL Graft Thickness on MRI
Time frame: MRI obtained during postoperative follow-up (≥6 months after surgery)
Postoperative Duration Group Comparison
Time frame: At a single postoperative assessment (6 and 12 months after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 32160507Alp 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.
- Background: PubMed 38378326Pasurka 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.
- Background: PubMed 36644094Panagopoulos 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.
- Background: PubMed 29589954Grasso 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture and Tendon Injuries, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity of Regenerated Hamstring Tendons Measured by Shear-Wave Elastography (time frame: At a single postoperative assessment (≥6 months after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07555782, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.