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

NCT06475963 | Completed

• 1 other identifier: STAR-ACT
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meniscus Lesion; Knee Osteoarthritis; Knee Injuries

Outcome Measures

Primary Outcomes (6)

• International Knee Documentation Committee

  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

  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)

• EuroQoL (quality of life) Current Health Assessment

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

  baseline (post surgery)

• EuroQoL Visual Analogue Scale (EQ-VAS)

  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)

• Tegner Score

  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)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  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)

Study Arms (1)

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

Interventions

surveys OTHER

telephone survey

patients

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (6)

• Houck DA, Kraeutler MJ, Belk JW, McCarty EC, Bravman JT. Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2018 Aug;26(8):2259-2269. doi: 10.1007/s00167-018-4838-1. Epub 2018 Jan 16.

  PMID: 29340746 RESULT

• Condello V, Dei Giudici L, Perdisa F, Screpis DU, Guerriero M, Filardo G, Zorzi C. Polyurethane scaffold implants for partial meniscus lesions: delayed intervention leads to an inferior outcome. Knee Surg Sports Traumatol Arthrosc. 2021 Jan;29(1):109-116. doi: 10.1007/s00167-019-05760-4. Epub 2019 Oct 25.

  PMID: 31654130 RESULT

• Filardo G, Kon E, Perdisa F, Sessa A, Di Martino A, Busacca M, Zaffagnini S, Marcacci M. Polyurethane-based cell-free scaffold for the treatment of painful partial meniscus loss. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):459-467. doi: 10.1007/s00167-016-4219-6. Epub 2016 Jul 9.

  PMID: 27395355 RESULT

• Grassi A, Zaffagnini S, Marcheggiani Muccioli GM, Benzi A, Marcacci M. Clinical outcomes and complications of a collagen meniscus implant: a systematic review. Int Orthop. 2014 Sep;38(9):1945-53. doi: 10.1007/s00264-014-2408-9. Epub 2014 Jun 20.

  PMID: 24947329 RESULT

• Zaffagnini S, Giordano G, Vascellari A, Bruni D, Neri MP, Iacono F, Kon E, Presti ML, Marcacci M. Arthroscopic collagen meniscus implant results at 6 to 8 years follow up. Knee Surg Sports Traumatol Arthrosc. 2007 Feb;15(2):175-83. doi: 10.1007/s00167-006-0144-4. Epub 2006 Jul 15.

  PMID: 16845545 RESULT

• Zaffagnini S, Marcheggiani Muccioli GM, Bulgheroni P, Bulgheroni E, Grassi A, Bonanzinga T, Kon E, Filardo G, Busacca M, Marcacci M. Arthroscopic collagen meniscus implantation for partial lateral meniscal defects: a 2-year minimum follow-up study. Am J Sports Med. 2012 Oct;40(10):2281-8. doi: 10.1177/0363546512456835. Epub 2012 Aug 20.

  PMID: 22915481 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Knee Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: March 17, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

IT (1)