Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee (STAR-ACT)

December 23, 2025 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from all subjects treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
Patients will be recruited from all subjects treated surgically with scaffolds for partial meniscal defects from January 01, 2009 to December 31, 2019
Other: surveys
telephone survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (post surgery)
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.
baseline (post surgery)
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.
baseline (post surgery)
EuroQoL (quality of life) Current Health Assessment
Time Frame: baseline (post surgery)
Valuable tool for measuring the quality of life of a patient.
baseline (post surgery)
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).
baseline (post surgery)
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.
baseline (post surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-ACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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