Anterior Cruciate Ligament RuptureACL ALLNCT07451743
Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction? Despite Numerous Technical Descriptions of Anterolateral Procedures, There is Limited Knowledge Regarding the Effect of Knee Flexion Angle During Graft Fixation.
A study testing anterolateral ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by ASL Lecce.
Trial summary
This study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- anterolateral ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to Jan 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a unilateral anterior cruciate ligament (ACL) rupture confirmed by clinical examination and magnetic resonance imaging (MRI)
- Persistent knee instability despite conservative treatment
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with the postoperative rehabilitation protocol and follow-up schedule
Who cannot join
- Previous ACL reconstruction or revision surgery on the affected knee
- Bilateral ACL injuries
- Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1
- Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)
- History of neurological, vestibular, or visual disorders affecting balance or gait
- Inflammatory joint disease or systemic musculoskeletal disorders
- Incomplete baseline clinical data
- Inability to complete patient-reported outcome questionnaires or attend follow-up visits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?
This study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction.
Combined ACL and ALL reconstruction is increasingly used to improve rotational knee stability and reduce the risk of graft failure after ACL injury. However, the optimal knee position for fixing the ALL graft during surgery remains unclear. In this study, patients were treated with ALL fixation performed either in full knee extension (0 degrees) or at 30 degrees of knee flexion.
Read more
Clinical outcomes, knee stability, patient-reported function, and graft failure rates were compared between the two groups at a minimum follow-up of two years. Outcomes were assessed using validated questionnaires, clinical examinations, and objective measurements of knee stability.
The study aims to determine whether the knee flexion angle at the time of ALL fixation influences postoperative function, stability, or complication rates, and to provide clinical evidence to guide surgical technique in combined ACL and ALL reconstruction.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- anterolateral ligament reconstruction
- Keywords
- acl, all, antepor cruciate ligament, anterolateral ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterolateral ligament reconstructionProcedure or surgery
Also called acl + all reconstruction
The intervention consists of a standardized combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction performed using anatomical single-bundle ACL reconstruction and anatomical ALL reconstruction. The surgical technique, graft selection, tunnel placement, fixation devices, and postoperative rehabilitation protocol are identical in both study arms.
The only variable distinguishing the interventions is the knee flexion angle at the time of femoral fixation of the ALL graft. In one group, the ALL graft is tensioned and fixed with the knee in full extension (0 degrees). In the other group, the ALL graft is tensioned and fixed with the knee positioned at 30 degrees of flexion. No intraoperative measurements of graft tension are performed, and fixation is carried out according to a predefined standardized protocol.
All procedures are performed by experienced surgeons using the same surgical landmarks for graft placement, with the intent of isolating the effect
| Study group | Role | What they receive |
|---|---|---|
| ALL Fixation at 0 Degrees of Knee Flexion | Active comparator | Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee in full extension (0 degrees) during surgery. Receives: Procedure: anterolateral ligament reconstruction |
| ALL Fixation at 30 Degrees of Knee Flexion | Active comparator | Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee flexed at 30 degrees during surgery. Receives: Procedure: anterolateral ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft rerupture rate
Graft rerupture is defined as a failure of the reconstructed anterior cruciate ligament (ACL), diagnosed by clinical evidence of knee instability and confirmed by imaging findings consistent with graft discontinuity or revision surgery.
Measured: 24 months
Secondary outcomes (4)
anterior knee laxity
Anterior knee laxity will be assessed as the side-to-side difference (in millimeters) between the operated and contralateral knee using a Rolimeter arthrometer.
Measured: 24 months
pivot shift test
Rotational knee stability will be evaluated using the pivot shift test, graded according to standard clinical classification (grade 0 to 3) by an experienced examiner.
Measured: 24 months
kinesiophobia
Fear of movement and reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK-11) questionnaire. range 11-44
Measured: 24 months
subjective knee function
Patient-reported knee function will be assessed using the International Knee Documentation Committee (IKDC) subjective knee evaluation form. range 0-100
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASL Lecce
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacopo Conteduca, ASL Lecce
- Investigators
- Jacopo Conteduca, MD, Study director, ASL Lecce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451743
- Sponsor's protocol ID
- Jacopo Conteduca
- Acronym
- ACL ALL
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations and the absence of a predefined data-sharing plan at the time of study design.
Publications
Kelly SR, Cutter BM, Huish EG Jr. Biomechanical Effects of Combined Anterior Cruciate Ligament Reconstruction and Anterolateral Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jun 24;9(6):23259671211009879. doi: 10.1177/23259671211009879. eCollection 2021 Jun.
PubMed 34250171Ariel de Lima D, de Lima LL, de Souza NGR, de Moraes Perez RA, Sobrado MF, Guimaraes TM, Helito CP. Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. Knee Surg Relat Res. 2021 Sep 23;33(1):33. doi: 10.1186/s43019-021-00115-1.
PubMed 34556187
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?
- ClinicalTrials.gov ID
- NCT07451743
- Acronym / sponsor ID
- ACL ALL / Jacopo Conteduca
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- acl, all, antepor cruciate ligament, anterolateral ligament
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ASL LecceOther government
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 5 Mar 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 study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction.
Combined ACL and ALL reconstruction is increasingly used to improve rotational knee stability and reduce the risk of graft failure after ACL injury. However, the optimal knee position for fixing the ALL graft during surgery remains unclear. In this study, patients were treated with ALL fixation performed either in full knee extension (0 degrees) or at 30 degrees of knee flexion.
Clinical outcomes, knee stability, patient-reported function, and graft failure rates were compared between the two groups at a minimum follow-up of two years. Outcomes were assessed using validated questionnaires, clinical examinations, and objective measurements of knee stability.
The study aims to determine whether the knee flexion angle at the time of ALL fixation influences postoperative function, stability, or complication rates, and to provide clinical evidence to guide surgical technique in combined ACL and ALL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL Fixation at 0 Degrees of Knee Flexion | Active comparator | Procedure: anterolateral ligament reconstructionParticipants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee in full extension (0 degrees) during surgery. |
| ALL Fixation at 30 Degrees of Knee Flexion | Active comparator | Procedure: anterolateral ligament reconstructionParticipants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee flexed at 30 degrees during surgery. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with a unilateral anterior cruciate ligament (ACL) rupture confirmed by clinical examination and magnetic resonance imaging (MRI)
- Persistent knee instability despite conservative treatment
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with the postoperative rehabilitation protocol and follow-up schedule
Key exclusion criteria (8 listed)
- Previous ACL reconstruction or revision surgery on the affected knee
- Bilateral ACL injuries
- Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1
- Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)
- History of neurological, vestibular, or visual disorders affecting balance or gait
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 |
|---|---|---|
| anterolateral ligament reconstructionAlso: acl + all reconstructionThe intervention consists of a standardized combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction performed using anatomical single-bundle ACL reconstruction and anatomical ALL reconstruction. The surgical technique, graft selection, tunnel placement, fixation devices, and postoperative rehabilitation protocol are identical in both study arms. The only variable distinguishing the interventions is the knee flexion angle at the time of femoral fixation of the ALL graft. In one group, the ALL graft is tensioned and fixed with the knee in full extension (0 degrees). In the other group, the ALL graft is tensioned and fixed with the knee positioned at 30 degrees of flexion. No intraoperative measurements of graft tension are performed, and fixation is carried out according to a predefined standardized protocol. All procedures are performed by experienced surgeons using the same surgical landmarks for graft placement, with the intent of isolating the effect | Procedure or surgery | ALL Fixation at 0 Degrees of Knee Flexion, ALL Fixation at 30 Degrees of Knee Flexion |
Primary outcome
graft rerupture rate
Time frame: 24 months
Graft rerupture is defined as a failure of the reconstructed anterior cruciate ligament (ACL), diagnosed by clinical evidence of knee instability and confirmed by imaging findings consistent with graft discontinuity or revision surgery.
4 secondary outcomes
anterior knee laxity
Time frame: 24 months
pivot shift test
Time frame: 24 months
kinesiophobia
Time frame: 24 months
subjective knee function
Time frame: 24 months
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 5 Mar 2026.
- Background: PubMed 34250171Kelly SR, Cutter BM, Huish EG Jr. Biomechanical Effects of Combined Anterior Cruciate Ligament Reconstruction and Anterolateral Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jun 24;9(6):23259671211009879. doi: 10.1177/23259671211009879. eCollection 2021 Jun.
- Background: PubMed 34556187Ariel de Lima D, de Lima LL, de Souza NGR, de Moraes Perez RA, Sobrado MF, Guimaraes TM, Helito CP. Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. Knee Surg Relat Res. 2021 Sep 23;33(1):33. doi: 10.1186/s43019-021-00115-1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations and the absence of a predefined data-sharing plan at the time of study design.
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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.
Jacopo Conteduca, MD study director
ASL Lecce
Questions about this trial
What is this clinical trial studying?
A study testing anterolateral ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by ASL Lecce.
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 8 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 5 Mar 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?
Contact Jacopo Conteduca, MD (0039 3332280645, CONTEDUCA85@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft rerupture rate (time frame: 24 months). 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 NCT07451743, which also lists 2 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 5 Mar 2026.