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

NCT07289412 | Recruiting

• 1 other identifier: Men Repair
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Suture, Complication; Ligament Laceration

Outcome Measures

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

  24 months after surgery

Secondary Outcomes (8)

• SPORTS (Subjective Patient Outcome for Return To Sports) Score

  24 months after surgery

• IMPACT activity level score

  24 months after surgery

• Lysholm Knee Score

  24 months after surgery

• Tegner Score

  24 months after surgery

• VAS (Visual Analog Scale)

  24 months after surgery

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefano Zaffagnini: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Central Study Contacts

stefano zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)