Anterior Cruciate Ligament InjuriesNCT06617559
Comparison of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction
A study testing Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft and Anterior Cruciate Ligament Reconstruction with Hamstring Autograft in people with Anterior Cruciate Ligament Injuries and Athletic Injuries, run by Muzaffer Agir at 1 site in Turkey (Türkiye).
Trial summary
With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Athletic Injuries, Tendon Graft; Complications
- What is being tested?
- Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft and Anterior Cruciate Ligament Reconstruction with Hamstring Autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to Mar 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elite athletes
- Amateur athletes
- Anterior cruciate ligament injury
Who cannot join
- Revision surgery
- Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
- > Grade-2 cartilage injury
- Having previously undergone surgery on the same knee
- < 18 years age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Fulya Hospital
Istanbul, 34394
Muzaffer Agir, +905543060011, muzafferagir@gmail.com
About this study
Official title: A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction
With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.
The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.
- Being tested
- Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft, Anterior Cruciate Ligament Reconstruction with Hamstring Autograft
- Keywords
- anterior cruciate ligament reconstruction, hamstring tendons, athletic injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cruciate Ligament Reconstruction with Quadriceps AutograftProcedure or surgery
The investigators will perform all-inside anterior cruciate ligament reconstruction using only the tendon portion of the quadriceps tendon (without bone fragments) in this group.
Anterior Cruciate Ligament Reconstruction with Hamstring AutograftProcedure or surgery
The investigators will perform all-inside anterior cruciate ligament reconstruction using the hamstring tendon as a graft in this group.
| Study group | Role | What they receive |
|---|---|---|
| All-inside Quadriceps Tendon Graft Group | Experimental | Not described Receives: Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft |
| All-inside Hamstring Tendon Graft Group | Experimental | Not described Receives: Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autograft Maturation
Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.
Measured: 12 months
Stability of Knee
Pivot shift test
Measured: 9 months
Stability of Knee
laxity measuring with KT-1000 device
Measured: 9 months
Stability of Knee
Lachman test
Measured: 9 months
Secondary outcomes (2)
Range of Motion
Measurement of knee flexion and extension degrees with a goniometer.
Measured: 6 months
Muscle Strength
Measurement of quadriceps and hamstring muscle strength with Cybex test
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 May 2024
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
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 InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two standard autografts used for ACL reconstruction in the investigators\' clinic: quadriceps and hamstring autografts. Patients will be randomly assigned to groups based on the order of their hospital admission. It is planned to have at least 25 patients in each group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muzaffer Agir
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem University
- Responsible party
- Sponsor-investigator, Muzaffer Agir, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617559
- Sponsor's protocol ID
- Fulyamaslak
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share de-identified individual participant data (IPD).
Publications
Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.
PubMed 30790526Lin KM, Boyle C, Marom N, Marx RG. Graft Selection in Anterior Cruciate Ligament Reconstruction. Sports Med Arthrosc Rev. 2020 Jun;28(2):41-48. doi: 10.1097/JSA.0000000000000265.
PubMed 32345925Cavaignac E, Coulin B, Tscholl P, Nik Mohd Fatmy N, Duthon V, Menetrey J. Is Quadriceps Tendon Autograft a Better Choice Than Hamstring Autograft for Anterior Cruciate Ligament Reconstruction? A Comparative Study With a Mean Follow-up of 3.6 Years. Am J Sports Med. 2017 May;45(6):1326-1332. doi: 10.1177/0363546516688665. Epub 2017 Mar 8.
PubMed 28273424Erden T, Agir M, Kayaalp ME, Toker B, Taser O. Prospective MRI-Based Comparison of Graft Maturation After ACL Reconstruction Using Quadriceps Versus Hamstring Tendon Autograft. Orthop J Sports Med. 2026 Jun 12;14(6):23259671261449148. doi: 10.1177/23259671261449148. eCollection 2026 Jun.
PubMed 42293038
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06617559
- Acronym / sponsor ID
- Fulyamaslak
- Keywords
- anterior cruciate ligament reconstruction, hamstring tendons, athletic injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Muzaffer AgirUniversity, hospital or other
- Collaborators
- Acibadem University
- Study start
- 14 May 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Sep 2024 (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.
With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.
The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two standard autografts used for ACL reconstruction in the investigators\' clinic: quadriceps and hamstring autografts. Patients will be randomly assigned to groups based on the order of their hospital admission. It is planned to have at least 25 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| All-inside Quadriceps Tendon Graft Group | Experimental | Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft |
| All-inside Hamstring Tendon Graft Group | Experimental | Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elite athletes
- Amateur athletes
- Anterior cruciate ligament injury
Key exclusion criteria (5 listed)
- Revision surgery
- Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
- > Grade-2 cartilage injury
- Having previously undergone surgery on the same knee
- < 18 years age
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 |
|---|---|---|
| Anterior Cruciate Ligament Reconstruction with Quadriceps AutograftThe investigators will perform all-inside anterior cruciate ligament reconstruction using only the tendon portion of the quadriceps tendon (without bone fragments) in this group. | Procedure or surgery | All-inside Quadriceps Tendon Graft Group |
| Anterior Cruciate Ligament Reconstruction with Hamstring AutograftThe investigators will perform all-inside anterior cruciate ligament reconstruction using the hamstring tendon as a graft in this group. | Procedure or surgery | All-inside Hamstring Tendon Graft Group |
Primary outcome
Autograft Maturation
Time frame: 12 months
Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.
Stability of Knee
Time frame: 9 months
Pivot shift test
Stability of Knee
Time frame: 9 months
laxity measuring with KT-1000 device
Stability of Knee
Time frame: 9 months
Lachman test
2 secondary outcomes
Range of Motion
Time frame: 6 months
Muscle Strength
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 30790526Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.
- Background: PubMed 32345925Lin KM, Boyle C, Marom N, Marx RG. Graft Selection in Anterior Cruciate Ligament Reconstruction. Sports Med Arthrosc Rev. 2020 Jun;28(2):41-48. doi: 10.1097/JSA.0000000000000265.
- Background: PubMed 28273424Cavaignac E, Coulin B, Tscholl P, Nik Mohd Fatmy N, Duthon V, Menetrey J. Is Quadriceps Tendon Autograft a Better Choice Than Hamstring Autograft for Anterior Cruciate Ligament Reconstruction? A Comparative Study With a Mean Follow-up of 3.6 Years. Am J Sports Med. 2017 May;45(6):1326-1332. doi: 10.1177/0363546516688665. Epub 2017 Mar 8.
- Derived from this study: PubMed 42293038Erden T, Agir M, Kayaalp ME, Toker B, Taser O. Prospective MRI-Based Comparison of Graft Maturation After ACL Reconstruction Using Quadriceps Versus Hamstring Tendon Autograft. Orthop J Sports Med. 2026 Jun 12;14(6):23259671261449148. doi: 10.1177/23259671261449148. eCollection 2026 Jun.
- Individual participant dataSharing planned: No. The investigators do not plan to share de-identified individual participant data (IPD).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft and Anterior Cruciate Ligament Reconstruction with Hamstring Autograft in people with Anterior Cruciate Ligament Injuries and Athletic Injuries, run by Muzaffer Agir 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muzaffer Agir, MD (+905543060011, muzafferagir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autograft Maturation (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT06617559, 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 Sep 2024.