Suture, ComplicationMen RepairNCT07289412
Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction
An observational study of Suture, Complication and Ligament Laceration, run by Stefano Zaffagnini at 1 site in Italy.
Trial summary
Meniscal tears are among the most common injuries of the knee joint. The average annual incidence is between 60 and 70 cases per 100,000 people. Among young athletes, these injuries account for 20-30% of all knee injuries, while in individuals over 50 they are frequently present even without symptoms (up to 60%). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Suture, Complication, Ligament Laceration
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 25 Feb 2026to Dec 2027
- Phase
- Observational
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited among both male and female subjects, aged 12 years or older and under 65 years at the time of surgery, who underwent meniscal repair using the all-inside technique for isolated meniscal lesions or lesions associated with other ligament injuries at the II Clinic of the Rizzoli Orthopedic Institute between 01/01/2017 and 30/06/2025. Only patients with a minimum follow-up of 2 years from the date of surgery will be enrolled
Who may be able to join
- Both male and female patients.
- Patients who underwent meniscal repair surgery using the all-inside technique for isolated meniscal lesions or lesions associated with ligament injuries between 01/01/2017 and 30/06/2025, with a minimum follow-up of two years.
- Patients aged between 12 and 65 years at the time of surgery.
- Patients who have provided consent to participate in the study.
- Patients who underwent preoperative radiological investigations (MRI) of the affected knee showing meniscal lesions requiring surgical treatment, also confirmed during diagnostic arthroscopy.
Who cannot join
- Meniscal lesions resulting from previous meniscal repairs.
- Patients younger than 12 years or older than 65 years at the time of surgery.
- Patients who did not provide informed consent.
- Patients who are no longer contactable.
- Patients who did not engage in sports activity in the 2 years prior to surgery
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, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
stefano zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
Meniscal tears are among the most common injuries of the knee joint. The average annual incidence is between 60 and 70 cases per 100,000 people. Among young athletes, these injuries account for 20-30% of all knee injuries, while in individuals over 50 they are frequently present even without symptoms (up to 60%). Meniscal tears often coexist with other intra-articular injuries: about one third of all cases occur together with an ACL rupture, which significantly increases the likelihood of a meniscal lesion. Possible treatments range from total meniscectomy, partial or selective meniscectomy, to meniscal suturing.
Compared with meniscectomy, meniscal repair preserves meniscal function and reduces the risk of progression to knee osteoarthritis from 51.42% (after meniscectomy) to 21.28% in patients who undergo meniscal repair. The main meniscal suture techniques are classified as inside-out, outside-in, and all-inside.
Read more
The present study aims to analyze the failure rates in patients who underwent meniscal repair using the all-inside technique at a single referral center, evaluating the complication rate, the need for reoperation, and the clinical satisfaction of the operated patients.
The results obtained aim to improve the understanding of the effectiveness of all-inside meniscal sutures-electively used at our referral center-compared with inside-out techniques.
The purpose of this study is to collect and analyze the cases of patients surgically treated with all-inside sutures for isolated meniscal tears or tears associated with other ligament injuries. The goal is to evaluate the survival and reoperation rates in patients who underwent all-inside meniscal repair for isolated meniscal injuries or those associated with ligament injuries, aged between 12 and 65 years, operated on at the II Clinic of the Rizzoli Orthopaedic Institute between 01/01/2017 and 30/06/2025, with a minimum follow-up of 2 years.
- Conditions
- Suture, Complication, Ligament Laceration
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Failures and reoperations will be recorded and documented within the CRF, during telephone questionnaires, and through the patient's clinical documentation
Measured: 24 months after surgery
Secondary outcomes (8)
SPORTS (Subjective Patient Outcome for Return To Sports) Score
This is a subjective questionnaire that assesses the level of return to sports activity compared to the pre-injury condition through a numerical scale consisting of 0, 3, 6, 9, and 10, accompanied by a verbal evaluation of athletic performance ranging from "disabled," corresponding to "0," to "good," corresponding to "10." These numerical values are arranged in increasing order in accordance with the assessment of return to sports activity relative to pre-injury performance
Measured: 24 months after surgery
IMPACT activity level score
It is an objective rating scale that allows the assessment of the level of impact on the knee based on the type of sport practiced. The different sports activities, according to their impact level, are classified as "Low," "Intermediate," and "High." This makes it possible to evaluate the impact level before and after surgery by comparing the type of sports activity performed by the patient prior to and following the surgical procedure
Measured: 24 months after surgery
Lysholm Knee Score
It is a validated measurement scale that assesses knee function through 8 items that allow the evaluation of the knee's condition in response to the functional demands of daily living activities. This assessment tool is used to evaluate surgical outcomes in patients undergoing procedures for ligament or meniscal knee injuries. The final score is obtained by summing the points from the various items and ranges from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (<64)
Measured: 24 months after surgery
Tegner Score
It allows the estimation of a subject's level of physical activity with a score ranging from 0 to 10, where 0 represents 'disability' and 10 represents 'participation in competitive sports, such as football at the national or international level.' This score is the most commonly used to define the activity level of patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview with the patient
Measured: 24 months after surgery
VAS (Visual Analog Scale)
It is a unidimensional quantitative 10-point numerical scale for pain assessment, represented by a 10 cm horizontal line without visible numerical markings, with the two ends labeled "no pain" (0) and "worst possible pain" (10). The patient is asked to mark a point on the line that represents the intensity of pain perceived at that moment. The investigator then measures the distance from the "0" point to quantify the pain. This scale will also be used to assess pre- and postoperative pain at the lateral compartment of the knee. This data will help evaluate the onset of pain following surgery at the site of placement of the metal chambers used for graft fixation in lateral tenodesis. Pain in the lateral femorotibial compartment reported as greater than 2 on the VAS scale will be considered as the presence of pain in the lateral compartment, while a value less than or equal to 2 will be considered as the absence of pain in the lateral compartment of the knee
Measured: 24 months after surgery
KOOS (Knee Injury and Ostearthritis Outcome Score) score
It is a subjective score composed of 42 questions divided into 5 main domains. These domains investigate different aspects of symptoms, daily activities, and knee-related quality of life, and are divided as follows:
- Symptoms: 7 questions, 2 regarding stiffness;
- Pain: 9 questions;
- Function and activities of daily living: 17 questions;
- Sport and recreational activities: 5 questions;
- Knee-related quality of life: 4 questions; All questions use the same response format, employing a quantitative scale from 0 (no problem) to 4 (severe difficulty). Scores are calculated separately for each domain and converted into a percentage score, where 100 represents excellent physical condition with no symptoms, and 0 represents severe disability with limitations in daily activities and constant symptoms even at rest.
Measured: 24 months after surgery
International Knee Documentation Committee (IKDC)
The IKDC form is a subjective knee evaluation tool that assesses the limitations a subject may experience in daily and sports activities, as well as the presence or absence of symptoms. The IKDC assessment consists of three main domains: Symptoms: including pain, stiffness, swelling, and feelings of locking; Sport and daily activities; Current knee function and function prior to injury.
The questionnaire comprises 10 questions: seven items assess the patient's symptoms, one item addresses sports participation, one item-composed of 9 points-evaluates the difficulties the patient experiences in performing daily living activities, and the final item measures the current knee function.
The score ranges from 0 to 100, with 100 representing no limitations or symptoms, indicating an excellent outcome. The further the score deviates from 100, the worse the result. Scores can be categorized into four groups: excellent (80-100), good (60-80), fair (30-60), and poor (0-30)
Measured: 24 months after surgery
Number of Participants with Radiological Assessment
Imaging materials available to the patient will be collected. And which one performed at a minimum follow-up of two years, already completed and in the patient's possession at the time of study participation, will be analyzed. The level of meniscal tissue healing will be assessed, and cartilage damage will be quantified using the ICRS Cartilage Score
Measured: 24 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 posted17 Dec 2025
- Study start25 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture, ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 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
- NCT07289412
- Sponsor's protocol ID
- Men Repair
- Acronym
- Men Repair
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07289412
- Acronym / sponsor ID
- Men Repair / Men Repair
- Conditions
- Suture, Complication, Ligament Laceration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
Meniscal tears are among the most common injuries of the knee joint. The average annual incidence is between 60 and 70 cases per 100,000 people. Among young athletes, these injuries account for 20-30% of all knee injuries, while in individuals over 50 they are frequently present even without symptoms (up to 60%). Meniscal tears often coexist with other intra-articular injuries: about one third of all cases occur together with an ACL rupture, which significantly increases the likelihood of a meniscal lesion. Possible treatments range from total meniscectomy, partial or selective meniscectomy, to meniscal suturing.
Compared with meniscectomy, meniscal repair preserves meniscal function and reduces the risk of progression to knee osteoarthritis from 51.42% (after meniscectomy) to 21.28% in patients who undergo meniscal repair. The main meniscal suture techniques are classified as inside-out, outside-in, and all-inside.
The present study aims to analyze the failure rates in patients who underwent meniscal repair using the all-inside technique at a single referral center, evaluating the complication rate, the need for reoperation, and the clinical satisfaction of the operated patients.
The results obtained aim to improve the understanding of the effectiveness of all-inside meniscal sutures-electively used at our referral center-compared with inside-out techniques.
The purpose of this study is to collect and analyze the cases of patients surgically treated with all-inside sutures for isolated meniscal tears or tears associated with other ligament injuries. The goal is to evaluate the survival and reoperation rates in patients who underwent all-inside meniscal repair for isolated meniscal injuries or those associated with ligament injuries, aged between 12 and 65 years, operated on at the II Clinic of the Rizzoli Orthopaedic Institute between 01/01/2017 and 30/06/2025, with a minimum follow-up of 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited among both male and female subjects, aged 12 years or older and under 65 years at the time of surgery, who underwent meniscal repair using the all-inside technique for isolated meniscal lesions or lesions associated with other ligament injuries at the II Clinic of the Rizzoli Orthopedic Institute between 01/01/2017 and 30/06/2025. Only patients with a minimum follow-up of 2 years from the date of surgery will be enrolled
Key inclusion criteria (5 listed)
- Both male and female patients.
- Patients who underwent meniscal repair surgery using the all-inside technique for isolated meniscal lesions or lesions associated with ligament injuries between 01/01/2017 and 30/06/2025, with a minimum follow-up of two years.
- Patients aged between 12 and 65 years at the time of surgery.
- Patients who have provided consent to participate in the study.
- Patients who underwent preoperative radiological investigations (MRI) of the affected knee showing meniscal lesions requiring surgical treatment, also confirmed during diagnostic arthroscopy.
Key exclusion criteria (5 listed)
- Meniscal lesions resulting from previous meniscal repairs.
- Patients younger than 12 years or older than 65 years at the time of surgery.
- Patients who did not provide informed consent.
- Patients who are no longer contactable.
- Patients who did not engage in sports activity in the 2 years prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate
Time frame: 24 months after surgery
Failures and reoperations will be recorded and documented within the CRF, during telephone questionnaires, and through the patient's clinical documentation
8 secondary outcomes
SPORTS (Subjective Patient Outcome for Return To Sports) Score
Time frame: 24 months after surgery
IMPACT activity level score
Time frame: 24 months after surgery
Lysholm Knee Score
Time frame: 24 months after surgery
Tegner Score
Time frame: 24 months after surgery
VAS (Visual Analog Scale)
Time frame: 24 months after surgery
KOOS (Knee Injury and Ostearthritis Outcome Score) score
Time frame: 24 months after surgery
International Knee Documentation Committee (IKDC)
Time frame: 24 months after surgery
Number of Participants with Radiological Assessment
Time frame: 24 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 16 Apr 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?
An observational study of Suture, Complication and Ligament Laceration, 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 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 16 Apr 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?
Survival rate (time frame: 24 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 16 Apr 2026.