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Not yet recruiting NCT06238947

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

— Observational Cartilage Injury Cartilage Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cartilage Injury, Cartilage Disease. Basic parameters: 14 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

LONG-TERM EVALUATION OF OUTCOMES OF PATIENTS UNDERGOING AUTOLOGOUS CHONDROCYTE TRANSPLANTATION DELIVERED ON BIOMATERIAL (HYALOGRAFT C) Prospective Observational Study

Overview

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

Detailed description

Patients will be recruited from all subjects surgically treated with autologous chondrocyte transplantation delivered on biomaterial for chondral/osteochondral lesions at the femoral condyles, trochlea, patella, and tibial plateau from 1999 to 2006 at the Rizzoli Orthopaedic Institute. The study has 3 phases: Identification of includable patients, Follow-up assessment byTelemedicine platform, and the collection of study-specific clinical data of enrolled patients.

Clinical score data will be collected from the medical records and questionnaires conducted in the mid-term of patients enrolled in the study. These data will be used, together with data collected by telemedicine/long-term e-mail questionnaire, to evaluate the time course of outcomes after surgical treatment with autologous chondrocyte transplantation delivered on biomaterial

Primary outcome measures

  • Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form [Time frame: baseline]
  • EuroQol Visual Analogue Scale (EQ-VAS ) [Time frame: baseline]
  • Tegner Score [Time frame: baseline]
  • EQ-5D (EuroQoL) Current Health Assessment [Time frame: baseline]
  • MCD/MCID (Minimal Clinically Important Difference): [Time frame: baseline]
  • Patient Acceptable Symptom State (PASS) [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients no longer available

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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 PMID 21782452
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06238947 · Chondro-Long

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗