Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds (CMI)

NCT06597357 | Completed DMC

• 1 other identifier: SUPER CMI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal sutures (where possible) to preserve as much meniscus as possible. Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis. However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical option. Over time, months or years later, a subgroup of patients may develop symptoms such as pain, joint swelling, and mechanical overload of the compartment that underwent meniscectomy, a condition known as post-meniscectomy syndrome..A portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement. In an attempt to treat this condition, scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery. The goal is to reduce the incidence of long-term osteoarthritis and, consequently, the need for more invasive procedures. To date, no study has definitively demonstrated the real efficacy of these scaffolds (CMI), particularly regarding chondroprotection and the long-term onset of osteoarthritis.

Conditions

Meniscal Degeneration; Osteoarthritis of Knee; Meniscus Injury

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC):

  The IKDC form is a subjective knee evaluation module that reflects the limitations on activities the individual can perform in daily life and sports, as well as the presence or absence of symptoms. There are three main domains in the IKDC evaluation form: Symptoms, which include pain, stiffness, swelling, and a sensation of locking; Sports and daily activities; Current knee function and function prior to injury. The questionnaire consists of 10 questions: seven items investigate the patient\'s symptoms, one item is focused on sports participation, one item-composed of 9 points-addresses the difficulties the patient experiences in performing daily life activities, and the last item measures the current functionality of the knee. The score ranges from 0 to 100, with 100 representing the absence of limitations and symptoms, indicating an excellent outcome; the further away from this score, the worse the result, which can be divided into four groups

  10 years after surgery

Secondary Outcomes (5)

• Lysholm Knee Score

  10 years after surgery

• VAS

  10 years after surgery

• SF-36 (Short Form-36 Health Survey)

  10 years after surgery

• Tegner Score

  10 years after surgery

• Radiographic evaluation

  10 years after surgery

Interventions

Arthroscopy & saline irrigation alone PROCEDURE

the meniscus scaffold is aimed at replacing partial meniscus defect with a synthetic device.

Eligibility Criteria

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

Study Population

Patients, upon signing the informed consent, will be clinically evaluated during the follow-up visit by specialized medical personnel. A clinical examination will be performed, including the administration of subjective assessment questionnaires, and weight-bearing radiographs of the lower limbs will be conducted.

You may qualify if:

• Patients aged between 18 and 65 years at the time of surgery
• Both male and female patients
• Patients who underwent meniscectomy and/or CMI implantation from January 1, 1998 to December 31, 2010 at the Rizzoli Orthopedic Institute.

You may not qualify if:

• Patients who are no longer reachable;
• Patients who do not consent to be included in the study;
• Presence of infection or hematological, rheumatic, or hemostatic disorders at the time of evaluation.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Rizzoli Orthopedic Institute

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroscopy; Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 29, 2020
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)