Anterior Cruciate Ligament (ACL) TearBTB vs QTNCT07846709
Bone-Patellar Tendon-Bone Versus Quadriceps Tendon Autograft for Anterior Cruciate Ligament Reconstruction: A Non-Inferiority Trial Regarding Anterior Knee Pain
A study testing Bone-Patellar Tendon-Bone Autograft ACL Reconstruction and Quadriceps Tendon Autograft ACL Reconstruction in people with Anterior Cruciate Ligament (ACL) Tear, run by Hospital del Mar.
Trial summary
This prospective, randomized, single-center, non-inferiority clinical trial will compare anterior knee pain (AKP) after primary anterior cruciate ligament (ACL) reconstruction using either a bone-patellar tendon-bone autograft (BPTB) or a quadriceps tendon autograft with a bone block (BQT). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- Bone-Patellar Tendon-Bone Autograft ACL Reconstruction and Quadriceps Tendon Autograft ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to Oct 2029
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical and/or radiological diagnosis of an anterior cruciate ligament (ACL) injury with an indication for primary surgical reconstruction.
- Ability to understand the study information and provide written informed consent.
- Willingness to participate in the study and complete the planned clinical and radiological follow-up.
- Technical feasibility of performing either a bone-patellar tendon-bone (BPTB) autograft or a quadriceps tendon autograft, as determined by the treating surgeon.
- Exclusion Criteria Previous surgery on the affected knee. Previous fracture of the proximal tibia, distal femur, or patella of the affected knee.
- History of patellofemoral pain syndrome, symptomatic insertional patellar tendinopathy, or symptomatic insertional quadriceps tendinopathy.
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- Need to harvest a graft that does not meet the predefined study specifications. Presence of a pain-amplifying condition or generalized chronic pain that could interfere with the assessment of anterior knee pain.
- Psychiatric, cognitive, or mental health disorders that may impair follow-up, understanding of the study, or valid completion of questionnaires.
- Medical contraindication to surgery or magnetic resonance imaging (MRI). Refusal to participate or withdrawal of informed consent.
Who cannot join
None listed.
About this study
Official title: Randomized Non-inferiority Clinical Trial Comparing Anterior Knee Pain After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Autograft Versus Quadriceps Tendon Autograft
This prospective, randomized, single-center, non-inferiority clinical trial will compare anterior knee pain (AKP) after primary anterior cruciate ligament (ACL) reconstruction using either a bone-patellar tendon-bone autograft (BPTB) or a quadriceps tendon autograft with a bone block (BQT).
Participants will be randomly assigned in a 1:1 ratio to one of the two graft groups. The primary objective is to determine whether BPTB is non-inferior to BQT with respect to AKP, as assessed by the change in pressure pain threshold from the preoperative measurement to 12 months after surgery.
Secondary outcomes will include kneeling pain, the Kujala Anterior Knee Pain Scale, the visual analog scale (VAS) for pain, quadriceps muscle circumference, the subjective International Knee Documentation Committee (IKDC) score, magnetic resonance imaging (MRI) findings, clinical stability, complications, associated surgical procedures, and graft failure.
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Being tested
- Bone-Patellar Tendon-Bone Autograft ACL Reconstruction, Quadriceps Tendon Autograft ACL Reconstruction
- Keywords
- Anterior cruciate ligament reconstruction, Bone-patellar tendon-bone autograft, Quadriceps tendon autograft, Anterior knee pain, Pressure algometry, Randomized clinical trial
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-Patellar Tendon-Bone Autograft ACL ReconstructionProcedure or surgery
BPTB Autograft ACL Reconstruction Primary ACL reconstruction using an autologous bone-patellar tendon-bone graft harvested from the central patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. Graft harvest and reconstruction will be performed using a standardized arthroscopic technique
Quadriceps Tendon Autograft ACL ReconstructionProcedure or surgery
Quadriceps Tendon Autograft ACL Reconstruction Primary ACL reconstruction using an autologous quadriceps tendon graft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be harvested as a partial-thickness quadriceps tendon graft using a standardized technique and implanted arthroscopically.
| Study group | Role | What they receive |
|---|---|---|
| Bone-Patellar Tendon-Bone Autograft | Experimental | Bone-Patellar Tendon-Bone Autograft Arm Participants will undergo primary anterior cruciate ligament (ACL) reconstruction using a bone-patellar tendon-bone (BPTB) autograft harvested from the central portion of the patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be implanted using the standardized arthroscopic ACL reconstruction technique routinely performed at the study center. Receives: Procedure: Bone-Patellar Tendon-Bone Autograft ACL Reconstruction |
| Quadriceps Tendon Autograft | Experimental | Quadriceps Tendon Autograft arm Participants will undergo primary anterior cruciate ligament reconstruction using a quadriceps tendon autograft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be harvested as a partial-thickness graft using a standardized technique and implanted using the same standardized arthroscopic ACL reconstruction principles. Receives: Procedure: Quadriceps Tendon Autograft ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure Pain Threshold mesured with presure algometry at the center of the Patella
Measured: Baseline to 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 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846709
- Sponsor's protocol ID
- 2026/12770/I
- Acronym
- BTB vs QT
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Clinical Trial Comparing Anterior Knee Pain After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Autograft Versus Quadriceps Tendon Autograft
- ClinicalTrials.gov ID
- NCT07846709
- Acronym / sponsor ID
- BTB vs QT / 2026/12770/I
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Keywords
- Anterior cruciate ligament reconstruction, Bone-patellar tendon-bone autograft, Quadriceps tendon autograft, Anterior knee pain, Pressure algometry, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 29 Sep 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.
This prospective, randomized, single-center, non-inferiority clinical trial will compare anterior knee pain (AKP) after primary anterior cruciate ligament (ACL) reconstruction using either a bone-patellar tendon-bone autograft (BPTB) or a quadriceps tendon autograft with a bone block (BQT).
Participants will be randomly assigned in a 1:1 ratio to one of the two graft groups. The primary objective is to determine whether BPTB is non-inferior to BQT with respect to AKP, as assessed by the change in pressure pain threshold from the preoperative measurement to 12 months after surgery.
Secondary outcomes will include kneeling pain, the Kujala Anterior Knee Pain Scale, the visual analog scale (VAS) for pain, quadriceps muscle circumference, the subjective International Knee Documentation Committee (IKDC) score, magnetic resonance imaging (MRI) findings, clinical stability, complications, associated surgical procedures, and graft failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone-Patellar Tendon-Bone Autograft | Experimental | Procedure: Bone-Patellar Tendon-Bone Autograft ACL ReconstructionBone-Patellar Tendon-Bone Autograft Arm Participants will undergo primary anterior cruciate ligament (ACL) reconstruction using a bone-patellar tendon-bone (BPTB) autograft harvested from the central portion of the patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be implanted using the standardized arthroscopic ACL reconstruction technique routinely performed at the study center. |
| Quadriceps Tendon Autograft | Experimental | Procedure: Quadriceps Tendon Autograft ACL ReconstructionQuadriceps Tendon Autograft arm Participants will undergo primary anterior cruciate ligament reconstruction using a quadriceps tendon autograft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be harvested as a partial-thickness graft using a standardized technique and implanted using the same standardized arthroscopic ACL reconstruction principles. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Clinical and/or radiological diagnosis of an anterior cruciate ligament (ACL) injury with an indication for primary surgical reconstruction.
- Ability to understand the study information and provide written informed consent.
- Willingness to participate in the study and complete the planned clinical and radiological follow-up.
- Technical feasibility of performing either a bone-patellar tendon-bone (BPTB) autograft or a quadriceps tendon autograft, as determined by the treating surgeon.
- Exclusion Criteria Previous surgery on the affected knee. Previous fracture of the proximal tibia, distal femur, or patella of the affected knee.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bone-Patellar Tendon-Bone Autograft ACL ReconstructionBPTB Autograft ACL Reconstruction Primary ACL reconstruction using an autologous bone-patellar tendon-bone graft harvested from the central patellar tendon, with bone blocks approximately 9-10 mm in diameter and 10-20 mm in length. Graft harvest and reconstruction will be performed using a standardized arthroscopic technique | Procedure or surgery | Bone-Patellar Tendon-Bone Autograft |
| Quadriceps Tendon Autograft ACL ReconstructionQuadriceps Tendon Autograft ACL Reconstruction Primary ACL reconstruction using an autologous quadriceps tendon graft with a bone block approximately 9-10 mm in diameter and 10-20 mm in length. The graft will be harvested as a partial-thickness quadriceps tendon graft using a standardized technique and implanted arthroscopically. | Procedure or surgery | Quadriceps Tendon Autograft |
Primary outcome
Change in Pressure Pain Threshold mesured with presure algometry at the center of the Patella
Time frame: Baseline to 12 months after surgery
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 7 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-Patellar Tendon-Bone Autograft ACL Reconstruction and Quadriceps Tendon Autograft ACL Reconstruction in people with Anterior Cruciate Ligament (ACL) Tear, run by Hospital del Mar.
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 9 inclusion and 0 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Pressure Pain Threshold mesured with presure algometry at the center of the Patella (time frame: Baseline to 12 months after surgery). 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 7 Oct 2026.