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Completed

NCT Number: NCT06597357

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

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.

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Key information

Conditions

Meniscal Degeneration Arthritis Joint Diseases Meniscus Injury Musculoskeletal Diseases Osteoarthritis Osteoarthritis of Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Arthroscopy & saline irrigation alone

Procedure

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

Primary outcomes

  1. International Knee Documentation Committee (IKDC):

    Time frame: 10 years after surgery

    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

Secondary outcomes

  1. Lysholm Knee Score

    Time frame: 10 years after surgery

    It is a validated measurement scale that assesses knee functionality through 8 items, allowing the evaluation of the knee's condition in response to the functional demands of daily activities. This assessment form is used to evaluate surgical outcomes in patients who have undergone surgery for ligament or meniscal injuries of the knee. The final score is obtained by summing the various scores from different items, ranging from 0 to 100.

    The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (<64).

  2. VAS

    Time frame: 10 years after surgery

    It is a unidimensional, quantitative numeric pain rating scale with 10 points; the scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that precise moment. 0 means no pain, and 10 indicates the worst possible pain

  3. SF-36 (Short Form-36 Health Survey)

    Time frame: 10 years after surgery

    It is the most well-known and widely used health-related quality of life measurement tool in international literature. It assesses different health concepts through 36 multiple-choice questions, with the data aggregated into 8 scales that evaluate: physical activity, role and physical health, physical pain, general health, vitality, social activities, role and emotional state, mental health. Additionally, there is one question regarding changes in health status over the past year.

  4. Tegner Score

    Time frame: 10 years after surgery

    It allows for estimating a person's level of physical activity with a score ranging from 0 to 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as national or international level football.' This score is the most commonly used to define the level of physical activity in patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview with the patient

  5. Radiographic evaluation

    Time frame: 10 years after surgery

    Clinical and imaging materials in the patient's possession will be collected to assess the potential development of osteoarthritis.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: SUPER CMI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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