Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial

NCT06238947 | Not Yet Recruiting

• 1 other identifier: Chondro-Long
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chondro-Long study is prospective observational study for a long-term clinical evaluation (follow-up up to 25 years) in patients treated with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) at the level of femoral condyles, trochlea, patella and tibial plateau. The aim of the study is to collect long-term clinical data from the case series of patients surgically treated from 1999 to 2006 with autologous chondrocyte transplantation delivered on biomaterial for full-thickness chondral defects (Outerbridge grade III - IV) or osteochondral defects at the level of femoral condyles, trochlea, patella, and tibial plateau. The objective of the study is to demonstrate the efficacy of this long-term cartilage regeneration technique (follow-up up to 25 years) in improving patient symptomatology and functional capacity

Conditions

Cartilage Injury; Cartilage Disease

Keywords

autologous chondrocyte transplantation; osteochondral defects

Outcome Measures

Primary Outcomes (6)

• Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form

  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

• 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

• Tegner Score

  This questionnaire 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 filled in directly by the investigator, through an interview the patient. In addition, questions will also be asked about return to sports and pre-injury, pre-treatment and recovered/achieved sports level .

  baseline

• EQ-5D (EuroQoL) Current Health Assessment

  EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys

  baseline

• MCD/MCID (Minimal Clinically Important Difference):

  the patient should indicate satisfaction and relative degree of improvement for the treatment performed

  baseline

• Patient Acceptable Symptom State (PASS)

  A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.

  baseline

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with autologous chondrocyte transplantation delivered on biomaterial (Hyalograft C, Fidia, Abano Terme ) for full-thickness chondral defects (Outerbridge grade III to IV) at the level of femoral condyles, trochlea, patella, and tibial plateau

You may qualify if:

• Patients who underwent autologous chondrocyte transplantation surgery delivered on biomaterial (Hyalograft C) from 1999 to 2006 at the Rizzoli Orthopaedic Institute who met the following criteria at the time of surgery:
• Full-thickness chondral defects (Outerbridge grade III - IV) and osteochondral defects at the femoral condyles, trochlea, patella and tibial plateau.
• Patients aged between 14 and 60 years at the time of surgery.
• Male and female sex.

You may not qualify if:

• Patients no longer available

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Related Publications (10)

• Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. 2006 Jan;34(1):128-35. doi: 10.1177/0363546505280214. Epub 2005 Oct 11.

  PMID: 16219941 BACKGROUND

• Aroen A, Loken S, Heir S, Alvik E, Ekeland A, Granlund OG, Engebretsen L. Articular cartilage lesions in 993 consecutive knee arthroscopies. Am J Sports Med. 2004 Jan-Feb;32(1):211-5. doi: 10.1177/0363546503259345.

  PMID: 14754746 BACKGROUND

• Bauer S, Khan RJ, Ebert JR, Robertson WB, Breidahl W, Ackland TR, Wood DJ. Knee joint preservation with combined neutralising high tibial osteotomy (HTO) and Matrix-induced Autologous Chondrocyte Implantation (MACI) in younger patients with medial knee osteoarthritis: a case series with prospective clinical and MRI follow-up over 5 years. Knee. 2012 Aug;19(4):431-9. doi: 10.1016/j.knee.2011.06.005. Epub 2011 Jul 22.

  PMID: 21782452 BACKGROUND

• Behrens P, Bitter T, Kurz B, Russlies M. Matrix-associated autologous chondrocyte transplantation/implantation (MACT/MACI)--5-year follow-up. Knee. 2006 Jun;13(3):194-202. doi: 10.1016/j.knee.2006.02.012. Epub 2006 Apr 24.

  PMID: 16632362 BACKGROUND

• Della Villa S, Kon E, Filardo G, Ricci M, Vincentelli F, Delcogliano M, Marcacci M. Does intensive rehabilitation permit early return to sport without compromising the clinical outcome after arthroscopic autologous chondrocyte implantation in highly competitive athletes? Am J Sports Med. 2010 Jan;38(1):68-77. doi: 10.1177/0363546509348490.

  PMID: 20051508 BACKGROUND

• de Windt TS, Bekkers JE, Creemers LB, Dhert WJ, Saris DB. Patient profiling in cartilage regeneration: prognostic factors determining success of treatment for cartilage defects. Am J Sports Med. 2009 Nov;37 Suppl 1:58S-62S. doi: 10.1177/0363546509349765.

  PMID: 19934438 BACKGROUND

• Ebert JR, Robertson WB, Woodhouse J, Fallon M, Zheng MH, Ackland T, Wood DJ. Clinical and magnetic resonance imaging-based outcomes to 5 years after matrix-induced autologous chondrocyte implantation to address articular cartilage defects in the knee. Am J Sports Med. 2011 Apr;39(4):753-63. doi: 10.1177/0363546510390476. Epub 2011 Jan 21.

  PMID: 21257846 BACKGROUND

• Ferruzzi A, Buda R, Faldini C, Vannini F, Di Caprio F, Luciani D, Giannini S. Autologous chondrocyte implantation in the knee joint: open compared with arthroscopic technique. Comparison at a minimum follow-up of five years. J Bone Joint Surg Am. 2008 Nov;90 Suppl 4:90-101. doi: 10.2106/JBJS.H.00633. No abstract available.

  PMID: 18984722 BACKGROUND

• Filardo G, Kon E, Andriolo L, Vannini F, Buda R, Ferruzzi A, Giannini S, Marcacci M. Does patient sex influence cartilage surgery outcome? Analysis of results at 5-year follow-up in a large cohort of patients treated with Matrix-assisted autologous chondrocyte transplantation. Am J Sports Med. 2013 Aug;41(8):1827-34. doi: 10.1177/0363546513480780. Epub 2013 Jul 15.

  PMID: 23857885 BACKGROUND

• Andriolo L, Reale D, Di Martino A, De Filippis R, Sessa A, Zaffagnini S, Filardo G. Long-term Results of Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation: A Prospective Follow-up at 15 Years. Am J Sports Med. 2020 Oct;48(12):2994-3001. doi: 10.1177/0363546520949849. Epub 2020 Sep 16.

  PMID: 32936677 BACKGROUND

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stefano Zaffagnini, MD

  Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Zaffagnini, MD

CONTACT

0516366567; stefano.zaffagnini@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

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

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01