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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-60
SponsorIstituto Ortopedico Rizzoli

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients no longer available

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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