Cruciate Ligament ReconstructionCandyStripeNCT07404046
Comparison of Tendon and Muscle-Tendon Semitendinosus Grafts After ACL Reconstruction
A study testing ACL reconstruction in people with Cruciate Ligament Reconstruction, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cruciate Ligament Reconstruction
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University hospital Dubrava
Zagreb, 10000
Marin Glavčić, MD, +385 1 290 2571, mglavcic@kbd.hr
About this study
Official title: Comparison of Bone Ingrowth and Intra-articular Remodeling of Autologous Tendon and Muscle-tendon Semitendinosus Graft After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
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.
Read the detailed description
This is a prospective, randomized clinical study conducted at Dubrava University Hospital. At least 40 patients aged 18 to 50 years with clinically and MRI-confirmed anterior cruciate ligament rupture and indication for concomitant lateral tenodesis will be enrolled. Participants will be randomly assigned in a 1:1 ratio to undergo arthroscopic all-inside ACL reconstruction using either a muscle-tendon semitendinosus graft (experimental group) or a standard tendon-only semitendinosus graft (control group). All surgical procedures will be performed by the same surgeon and supplemented with modified Lemaire lateral tenodesis.
Clinical assessments will be performed preoperatively and at 6 weeks, 6 and 12 months postoperatively and will include validated patient-reported outcome measures (EQ-5D and KOOS) and a non-validated Croatian version of the IKDC Subjective Knee Evaluation Form. Knee stability will be assessed 12 months postoperatively using a digital Lachmeter device.
Magnetic resonance imaging of the operated knee will be performed at 6 weeks, 6 and 12 months using a standardized 3T MRI protocol including proton density sequences and T2 mapping. Intra-articular graft remodeling will be assessed using the signal-to-noise quotient method, with standardized regions of interest placed at the proximal, middle, and distal portions of the intra-articular graft and at the posterior cruciate ligament. Tendon-to-bone healing will be evaluated by measuring femoral and tibial tunnel diameters and calculating percentage tunnel widening relative to intraoperative tunnel size.
All participants will follow identical postoperative rehabilitation protocols. MRI analysis will be performed by two experienced musculoskeletal radiologists blinded to group allocation.
- Conditions
- Cruciate Ligament Reconstruction
- Being tested
- ACL reconstruction
- Keywords
- Arthroscopy, Tissue Remodeling, Anterior Cruciate Ligament, Semitendinosus Muscle, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks, 6 and 12 months postoperatively
Secondary outcomes (9)
Bone Tunnel Diameter - Femur
Description: The diameter of the femoral bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter.
Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening
Measured: 6 weeks, 6 months, 12 months postoperatively
Bone Tunnel Diameter - Tibia
Description: The diameter of the tibial bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter.
Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening.
Measured: 6 weeks, 6 months, 12 months postoperatively
Knee Stability - Anterior Tibial Translation
Description: The anterior-posterior stability of the operated knee measured with the Lachmeter device at 12 months postoperatively.
Units: Millimeters (mm) of anterior tibial translation Directionality: Higher values indicate greater laxity (worse stability)
Measured: 12 months postoperatively
KOOS - Pain Subscale
Description: Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale, assessing knee pain.
Scale: 0-100 (0 = extreme pain, 100 = no pain; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Symptoms Subscale
Description: KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness).
Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Activities of Daily Living (ADL) Subscale
Description: KOOS - ADL subscale, assessing functional ability in daily activities.
Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Sports/Recreation Subscale
Description: KOOS - Sports/Recreation subscale, assessing function during sport or recreational activity.
Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Quality of Life (QoL) Subscale
Description: KOOS - QoL subscale, assessing knee-related quality of life. Scale: 0-100 (0 = extreme problem, 100 = no problem; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
IKDC-SKF (International Knee Documentation Committee - Subjective Knee Form)
Description: Patient-reported measure of knee function, symptoms, and sports activity.
Scale: 0-100 (0 = worst knee function, 100 = best knee function; higher scores = better outcome)
Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cruciate Ligament ReconstructionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marin Glavčić, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404046
- Sponsor's protocol ID
- 2024/0719-3
- Acronym
- CandyStripe
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bone Ingrowth and Intra-articular Remodeling of Autologous Tendon and Muscle-tendon Semitendinosus Graft After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT07404046
- Acronym / sponsor ID
- CandyStripe / 2024/0719-3
- Conditions
- Cruciate Ligament Reconstruction
- Keywords
- Arthroscopy, Tissue Remodeling, Anterior Cruciate Ligament, Semitendinosus Muscle, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Feb 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.
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.
Detailed description
This is a prospective, randomized clinical study conducted at Dubrava University Hospital. At least 40 patients aged 18 to 50 years with clinically and MRI-confirmed anterior cruciate ligament rupture and indication for concomitant lateral tenodesis will be enrolled. Participants will be randomly assigned in a 1:1 ratio to undergo arthroscopic all-inside ACL reconstruction using either a muscle-tendon semitendinosus graft (experimental group) or a standard tendon-only semitendinosus graft (control group). All surgical procedures will be performed by the same surgeon and supplemented with modified Lemaire lateral tenodesis.
Clinical assessments will be performed preoperatively and at 6 weeks, 6 and 12 months postoperatively and will include validated patient-reported outcome measures (EQ-5D and KOOS) and a non-validated Croatian version of the IKDC Subjective Knee Evaluation Form. Knee stability will be assessed 12 months postoperatively using a digital Lachmeter device.
Magnetic resonance imaging of the operated knee will be performed at 6 weeks, 6 and 12 months using a standardized 3T MRI protocol including proton density sequences and T2 mapping. Intra-articular graft remodeling will be assessed using the signal-to-noise quotient method, with standardized regions of interest placed at the proximal, middle, and distal portions of the intra-articular graft and at the posterior cruciate ligament. Tendon-to-bone healing will be evaluated by measuring femoral and tibial tunnel diameters and calculating percentage tunnel widening relative to intraoperative tunnel size.
All participants will follow identical postoperative rehabilitation protocols. MRI analysis will be performed by two experienced musculoskeletal radiologists blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tendon | Active comparator | Procedure: ACL reconstructionIntervention 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 |
| Tendon + meniscus | Active comparator | Procedure: ACL reconstructionIntervention 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 |
| Muscle tendon | Active comparator | Procedure: ACL reconstructionIntervention 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 |
| Muscle tendon + meniscus | Active comparator | Procedure: ACL reconstructionIntervention 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ACL reconstructionParticipants 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. | Procedure or surgery | Muscle tendon, Muscle tendon + meniscus, Tendon, Tendon + meniscus |
Primary outcome
SNQ
Time frame: 6 weeks, 6 and 12 months postoperatively
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).
9 secondary outcomes
Bone Tunnel Diameter - Femur
Time frame: 6 weeks, 6 months, 12 months postoperatively
Bone Tunnel Diameter - Tibia
Time frame: 6 weeks, 6 months, 12 months postoperatively
Knee Stability - Anterior Tibial Translation
Time frame: 12 months postoperatively
KOOS - Pain Subscale
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Symptoms Subscale
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Activities of Daily Living (ADL) Subscale
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Sports/Recreation Subscale
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
KOOS - Quality of Life (QoL) Subscale
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
IKDC-SKF (International Knee Documentation Committee - Subjective Knee Form)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction in people with Cruciate Ligament Reconstruction, run by University Hospital Dubrava at 1 site in Croatia.
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 5 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: looking for participants now, as of the sponsor's last update on 11 Feb 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marin Glavčić, MD (+385 1 290 2571, mglavcic@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNQ (time frame: 6 weeks, 6 and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.