Clinical trial NCT06238947: Long-term Outcome Evaluation of Patients Undergoing Autologous Chondrocyte Transplantation Delivered on Biomaterial
Official title: LONG-TERM EVALUATION OF OUTCOMES OF PATIENTS UNDERGOING AUTOLOGOUS CHONDROCYTE TRANSPLANTATION DELIVERED ON BIOMATERIAL (HYALOGRAFT C) Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cartilage Injury
Cartilage Disease
Keywords: autologous chondrocyte transplantation
osteochondral defects
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (IKDC)-Subjective Knee Evaluation Form
timeFrame: baseline
measure: EuroQol Visual Analogue Scale (EQ-VAS )
timeFrame: baseline
measure: Tegner Score
timeFrame: baseline
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline
measure: MCD/MCID (Minimal Clinically Important Difference):
timeFrame: baseline
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
name: Stefano Zaffagnini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.