Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-65
SponsorStefano Zaffagnini

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Survival rate

Failures and reoperations will be recorded and documented within the CRF, during telephone questionnaires, and through the patient's clinical documentation

Time frame
24 months after surgery

Secondary outcomes

1

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

Time frame
24 months after surgery
2

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

Time frame
24 months after surgery
3

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)

Time frame
24 months after surgery
4

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

Time frame
24 months after surgery

Other outcomes

Sponsors and contacts

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Stefano Zaffagnini

Lead sponsor

Istituto Ortopedico Rizzoli

Sponsor institution