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Not yet recruitingNCT06238947Updated Jul 1, 2026

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

An observational study in Cartilage Injury and Cartilage Disease, sponsored by Istituto Ortopedico Rizzoli. Not yet recruiting. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
14 Years to 60 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Cartilage Injury
  • Cartilage Disease

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Keywords

  • autologous chondrocyte transplantation
  • osteochondral defects
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In context

Cartilage Diseases

38 studies on the registry are indexed under Cartilage Diseases; 3 are open to participants now.

This study's planned enrollment of 200 is above the median of 73 across 11 observational studies indexed under Cartilage Diseases.

Browse Cartilage Diseases studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients no longer available
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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).

    Time frame: baseline

  3. 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 .

    Time frame: baseline

  4. 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

    Time frame: baseline

  5. MCD/MCID (Minimal Clinically Important Difference):

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

    Time frame: baseline

  6. 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.

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 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. PubMed 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. Epub 2011 Jul 22. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 18984722 ↗
  • 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. PubMed 23857885 ↗
  • 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. PubMed 32936677 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2024
First posted
Feb 2, 2024
StartEst.
Sep 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06238947
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Sep 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

Stefano Zaffagnini, MD
Contact
stefano.zaffagnini@ior.it
0516366567
Roberta Licciardi, MSc
Contact
roberta.licciardi@ior.it
6366567 ext. 051
Stefano Zaffagnini, MD
principal investigator · Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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