ACL ReconstructionMetal-free OTTNCT07819929
Mid-term Postoperative Clinical Evaluation of Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Using the Over-The-Top Technique, Fixed With Metal Staples or Soft Anchors.
A study testing ACL reconstruction using the Over-The-Top technique in people with ACL Reconstruction and Fixation, run by Stefano Zaffagnini at 1 site in Italy.
Trial summary
Anterior cruciate ligament (ACL) reconstruction is a widely performed procedure aimed at restoring knee stability and enabling return to sports activities. The Over-The-Top (OTT) technique is a well-established option, particularly in complex and revision cases, due to its ability to provide both anteroposterior and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Reconstruction, Fixation
- What is being tested?
- ACL reconstruction using the Over-The-Top technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2026to Aug 2030
- 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
- Patients of either sex, aged between 18 and 50 years at the time of surgery;
- Patients with an isolated anterior cruciate ligament (ACL) injury, with or without associated meniscal lesions, scheduled for ACL reconstruction and meniscal treatment; .3 Patients whose contralateral knee has never undergone meniscectomy, ligament reconstruction, unicompartmental knee arthroplasty, or total knee arthroplasty;
- 4. Patients who have signed the informed consent form.
Who cannot join
- Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL);
- Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT);
- Patients who underwent total or subtotal medial or lateral meniscectomy;
- Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery;
- Patients who are unable to provide informed consent or who are unwilling to provide informed consent;
- Patients with insufficient and/or compromised bone quality or quantity due to disease, infection, or previous implantation, such that adequate support and/or fixation of the devices cannot be ensured;
- Patients with limited blood supply or a history of infections that could delay healing;
- Patients with sensitivity to foreign materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Rizzoli Orthopedic Institute
Bologna, 40136
Stefano Zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
Official title: Mid-term Postoperative Clinical Evaluation of Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Using the Over-The-Top Technique, Fixed With Metal Staples or Soft Anchors
Anterior cruciate ligament (ACL) reconstruction is a widely performed procedure aimed at restoring knee stability and enabling return to sports activities. The Over-The-Top (OTT) technique is a well-established option, particularly in complex and revision cases, due to its ability to provide both anteroposterior and rotational stability. Long-term studies have reported favorable clinical outcomes, with low failure rates.
Graft fixation is an important technical aspect that may influence postoperative outcomes. Traditionally, the OTT technique has been performed using metal staples, which provide reliable primary fixation but may cause local complications and sometimes require subsequent removal due to pain or discomfort.
Read more
More recently, suture-based fixation devices, such as Knee FiberTak anchors (Arthrex), have been introduced as a metal-free alternative. These devices allow graft fixation through high-strength sutures, providing stable graft-to-bone contact while minimizing bony invasiveness and hardware prominence.
The present study aims to evaluate the clinical, functional, and instrumental outcomes of ACL reconstruction using the OTT technique with graft fixation by suture anchors compared with traditional metal staples. Particular attention will be paid to postoperative knee stability, assessed using validated instruments (KT-1000 and KiRA), as well as failure rates, reoperations, and complications.
- Conditions
- ACL Reconstruction, Fixation
- Being tested
- ACL reconstruction using the Over-The-Top technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction using the Over-The-Top techniqueProcedure or surgery
The procedure involves ACL reconstruction using the Over-The-Top technique, with the graft positioned over the lateral femoral condyle to provide anteroposterior and rotational stability.
The graft is secured using either metal staples or suture anchors, according to the assigned fixation technique.
| Study group | Role | What they receive |
|---|---|---|
| Metal staples | Active comparator | Not described Receives: Procedure: ACL reconstruction using the Over-The-Top technique |
| Soft anchors | Experimental | Not described Receives: Procedure: ACL reconstruction using the Over-The-Top technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT-1000
The KT-1000 is a clinical-instrumental test widely used for the standardized assessment of patients undergoing anterior cruciate ligament (ACL) reconstruction. It provides an objective measurement of anterior-posterior knee laxity and is extensively used in both clinical practice and scientific research.
The assessment is performed with the patient in a supine position, with the knee flexed to approximately 30° and supported on a dedicated device. The examiner applies a standardized anterior load to the tibia while stabilizing the femur, and the resulting anterior-posterior displacement is recorded by sensors positioned in contact with the patella and tibial tuberosity.
The measurement does not have a predefined minimum or maximum value. Lower values indicate less anterior laxity and therefore better knee stability, whereas higher values indicate greater anterior laxity and worse knee stability.
Measured: At least 24 months
Secondary outcomes (8)
KiRA
For quantitative assessment of the Pivot Shift test, the KiRA sensor is secured to the skin over the anterolateral proximal tibia, specifically at the level of Gerdy's tubercle, using a hypoallergenic strap and an appropriate support to optimize stability. The device, which incorporates a triaxial accelerometer and gyroscope, communicates wirelessly with a dedicated application installed on a tablet, providing real-time quantification of tibial displacement during the clinical maneuver.
KiRA measurements are expressed in millimeters (mm) and represent the magnitude of anterior tibial displacement. There is no predefined minimum or maximum value for this continuous measurement; lower values indicate less tibial displacement and therefore better rotational stability, whereas higher values indicate greater displacement and worse rotational stability.
Measured: At least 24 months
IKDC standard evaluation form
This is a clinical assessment form completed by the physician following a thorough physical examination of the knee. It includes several clinical tests to assess joint deformities, objective instability, and meniscal injuries. The resulting score determines an objective functional grade, classified from A to D: A, normal; B, nearly normal; C, moderately abnormal; and D, severely abnormal.
Measured: At least 24 months
Lysholm Knee Score
This is a validated outcome measure that assesses knee function through 8 items designed to evaluate the knee's ability to meet the functional demands of daily activities. It is commonly used to assess surgical outcomes in patients undergoing treatment for knee ligament or meniscal injuries.
The final score is calculated by summing the scores obtained across the individual items, ranging from 0 to 100. Scores are classified as Excellent (95-100), Good (84-94), Fair (65-83), and Poor (<64).
Measured: At least 24 months
VAS
This is a 10-point unidimensional numerical scale used to assess pain intensity. The patient selects the number that best represents their pain intensity at that specific moment, ranging from 0 (no pain) to 10 (worst possible pain)
Measured: At least 24 months
SF-12 (Short Form-12 Health Survey)
This is a 12-item multiple-choice questionnaire that provides two main summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Together, these scores provide a concise and reliable assessment of the patient's overall health status.
Scores are typically reported on a 0-100 scale, with higher scores indicating better health-related quality of life.
Measured: At least 24 months
KOOS (Knee Injury and Osteoarthritis Outcome Score)
This is a validated, knee-specific outcome measure used to assess symptoms and function in patients with ligament injuries or degenerative knee conditions. It consists of five subscales: Pain, Other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life (QOL), providing a comprehensive assessment of the impact of knee pathology and treatment on joint function and quality of life.
Each subscale is scored from 0 to 100, with higher scores indicating better knee function and fewer symptoms, while lower scores indicate worse outcomes.
Measured: At least 24 months
Tegner Score
The Tegner Activity Scale is a validated measure used to assess the patient's level of physical activity on a scale from 0 to 10, where 0 represents disability and 10 represents participation in competitive sports at a national or international level, such as football.
It is widely used to assess activity levels in patients with knee disorders. Patients will also be asked how many years they have been physically active in sports and whether any reduction or cessation of sporting activity is related to their knee condition.
Measured: At least 24 months
Patient Satisfaction
To assess the patient's level of satisfaction, patients will be asked the following question: "Are you satisfied with the surgical procedure?" The response will be dichotomous (yes/no)
Measured: At least 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL 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
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819929
- Sponsor's protocol ID
- Metal-free OTT
- Acronym
- Metal-free OTT
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Postoperative Clinical Evaluation of Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Using the Over-The-Top Technique, Fixed With Metal Staples or Soft Anchors
- ClinicalTrials.gov ID
- NCT07819929
- Acronym / sponsor ID
- Metal-free OTT / Metal-free OTT
- Conditions
- ACL Reconstruction, Fixation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 15 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.
Anterior cruciate ligament (ACL) reconstruction is a widely performed procedure aimed at restoring knee stability and enabling return to sports activities. The Over-The-Top (OTT) technique is a well-established option, particularly in complex and revision cases, due to its ability to provide both anteroposterior and rotational stability. Long-term studies have reported favorable clinical outcomes, with low failure rates.
Graft fixation is an important technical aspect that may influence postoperative outcomes. Traditionally, the OTT technique has been performed using metal staples, which provide reliable primary fixation but may cause local complications and sometimes require subsequent removal due to pain or discomfort.
More recently, suture-based fixation devices, such as Knee FiberTak anchors (Arthrex), have been introduced as a metal-free alternative. These devices allow graft fixation through high-strength sutures, providing stable graft-to-bone contact while minimizing bony invasiveness and hardware prominence.
The present study aims to evaluate the clinical, functional, and instrumental outcomes of ACL reconstruction using the OTT technique with graft fixation by suture anchors compared with traditional metal staples. Particular attention will be paid to postoperative knee stability, assessed using validated instruments (KT-1000 and KiRA), as well as failure rates, reoperations, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal staples | Active comparator | Procedure: ACL reconstruction using the Over-The-Top technique |
| Soft anchors | Experimental | Procedure: ACL reconstruction using the Over-The-Top technique |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of either sex, aged between 18 and 50 years at the time of surgery;
- Patients with an isolated anterior cruciate ligament (ACL) injury, with or without associated meniscal lesions, scheduled for ACL reconstruction and meniscal treatment; .3 Patients whose contralateral knee has never undergone meniscectomy, ligament reconstruction, unicompartmental knee arthroplasty, or total knee arthroplasty;
- 4. Patients who have signed the informed consent form.
Key exclusion criteria (8 listed)
- Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL);
- Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT);
- Patients who underwent total or subtotal medial or lateral meniscectomy;
- Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery;
- Patients who are unable to provide informed consent or who are unwilling to provide informed consent;
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 reconstruction using the Over-The-Top techniqueThe procedure involves ACL reconstruction using the Over-The-Top technique, with the graft positioned over the lateral femoral condyle to provide anteroposterior and rotational stability. The graft is secured using either metal staples or suture anchors, according to the assigned fixation technique. | Procedure or surgery | Metal staples, Soft anchors |
Primary outcome
KT-1000
Time frame: At least 24 months
The KT-1000 is a clinical-instrumental test widely used for the standardized assessment of patients undergoing anterior cruciate ligament (ACL) reconstruction. It provides an objective measurement of anterior-posterior knee laxity and is extensively used in both clinical practice and scientific research. The assessment is performed with the patient in a supine position, with the knee flexed to approximately 30° and supported on a dedicated device. The examiner applies a standardized anterior load to the tibia while stabilizing the femur, and the resulting anterior-posterior displacement is recorded by sensors positioned in contact with the patella and tibial tuberosity. The measurement does not have a predefined minimum or maximum value. Lower values indicate less anterior laxity and therefore better knee stability, whereas higher values indicate greater anterior laxity and worse knee stability.
8 secondary outcomes
KiRA
Time frame: At least 24 months
IKDC standard evaluation form
Time frame: At least 24 months
Lysholm Knee Score
Time frame: At least 24 months
VAS
Time frame: At least 24 months
SF-12 (Short Form-12 Health Survey)
Time frame: At least 24 months
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: At least 24 months
Tegner Score
Time frame: At least 24 months
Patient Satisfaction
Time frame: At least 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 15 Sep 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.
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 using the Over-The-Top technique in people with ACL Reconstruction and Fixation, run by Stefano Zaffagnini at 1 site in Italy.
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 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 15 Sep 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 Italy. 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 Stefano Zaffagnini (0516366075, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KT-1000 (time frame: At least 24 months). 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 15 Sep 2026.