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OpenTrials
Completed

NCT Number: NCT06475963

Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee

The study consists of 3 phases (Identification of includable patients, Telephone follow-up evaluation and the collection of study-specific clinical data in medical records of enrolled patients):

* Identification by trained medical personnel of subjects who meet the study's inclusion criteria. * Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted by telephone. * Study-specific clinical score data will be collected from the medical records of patients enrolled in the study. These data will be used, together with the data collected during the telephone follow-up, to evaluate the trend in outcomes over time after implantation of this scaffold.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Injuries Leg Injuries Meniscus Lesion Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute irreparable meniscal injuries requiring partial meniscectomy or chronic meniscal tissue loss (traumatic or degenerative) greater than 25%; Intact anterior and posterior meniscal horn respectively;
  • Peripheral meniscal rim (1 mm or more) along the entire circumference of the involved meniscus;
  • Knee stability or anterior cruciate ligament injury stabilized at the time of surgery;
  • Male or female patients between the ages of 18 and 65 years;
  • Healthy contralateral knee;
  • Normal axial alignment of the knee (mechanical tibio-femoral angle < 3°)
  • Patients treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019

Exclusion criteria

  • Patients no longer available;
  • Concomitant posterior cruciate ligament (PCL) injury;
  • Advanced cartilage injuries according to Outerbridge classification (IV);
  • Incorrect axial alignment of the lower limb;
  • Documented allergy to polyurethane;
  • Local or systemic infection;
  • History of previous anaphylactoid reaction;
  • Systemic administration of corticosteroids or immunosuppressive drugs within 30 days prior to surgery;
  • Evidence of osteonecrosis in the involved knee;
  • Positive history of rheumatoid arthritis, inflammatory arthritis and autoimmune diseases;
  • Neurological disorders or conditions that may affect the rehabilitation protocol;
  • Pregnancy.

Treatment and study plan

Surveys

Other

telephone survey

Primary outcomes

  1. International Knee Documentation Committee

    Time frame: baseline (post surgery)

    This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, where a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.

  2. Visual Analogue Scale pain

    Time frame: baseline (post surgery)

    It is a one-dimensional quantitative 11-point numeric pain rating scale; the scale requires the patient to select the number that best describes the intensity of his or her pain, from 0 to 10, at that specific time. 0 means no pain and 10 indicates the worst possible pain.

  3. EuroQoL (quality of life) Current Health Assessment

    Time frame: baseline (post surgery)

    Valuable tool for measuring the quality of life of a patient.

  4. EuroQoL Visual Analogue Scale (EQ-VAS)

    Time frame: baseline (post surgery)

    This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).

  5. Tegner Score

    Time frame: baseline (post surgery)

    It allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. In the study, the Tegner Score will be compiled directly by the investigator, through an interview the patient.

  6. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: baseline (post surgery)

    It is a pathology-specific questionnaire useful for the assessment of symptoms reported at the knee joint level in patients with osteoarthritis.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee, an Observational Study.

Acronym: STAR-ACT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Dec 24, 2025

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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