E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic focal cartilage defects in the knee |
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E.1.1.1 | Medical condition in easily understood language |
Painful cartilage injuries of the knee. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
A randomized controlled trial comparing Autologous Chondrocyte Implantation with arthroscopic debridement |
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E.2.2 | Secondary objectives of the trial |
To conduct a treatment-cost analysis for the two different treatments of cartilage injuries. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Patients accepting enrollment, will also be asked participation in the “Healer-NonHealer” project run by Professor J. Brinchmann at Oslo University Hospital – Rikshospitalet. Patients will have a 5 mL venous blood sample drawn as described in Section “5.4 Operative procedure – blood samples for parallel study”. The fasting blood sample will be taken after 30 minutes of bedrest, to limit the influence of preceding physical activity.
With this blood sample, we want to investigate the concentration of microRNA-140 (miR-140). MicroRNAs (miRNAs) are a class of endogenous and non-coding single-strand RNAs, and have been associated with various diseases. MiR-140 is cartilage specific, is the most prevalent miR in normal human cartilage and have shown to regulate homeostasis and development ofcartilage. It has been found to play a significant role in cartilage pathogenesis. Deletion of miR-140 in mice predisposed to osteoarthritis (OA) like changes, and decreased expression of miR-140 in OA cartilage may contribute to the abnormal gene expression pattern characteristic of OA.
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E.3 | Principal inclusion criteria |
-Age 18-50 years old
-Single symptomatic cartilage defect on medial or lateral femoral condyle or trochlea
-Defect size larger than 2 cm2
-Defect ICRS grade 3-4
-Ligamentous stable knee
-Acceptable range of motion (minimum 5-105 °)
- Lysholm score < 75
-Informed consent
-Meniscus > 50 % intact
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E.4 | Principal exclusion criteria |
-Osteoarthritis, rheumatoid or other systemic arthritis (asked)
-Malalignment > 5° measured on HKA x-rays
-No radiological osteoarthritis
-Obesity (Body mass index > 30)
-Comorbidities that may influence surgery or rehabilitation
-Pregnancy
-Inability to complete questionnaires or rehabilitation
-Serious alcohol or drug abuse
- Previous cartilage surgery to the chondral defect except OCD surgery
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E.5 End points |
E.5.1 | Primary end point(s) |
KOOS score (quality of life)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (before surgery) and at 3,6,12, and 24 months. |
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E.5.2 | Secondary end point(s) |
KOOS score (Except Quality of life subscore, which is the primary end point).
Tegner score
Lysholm score
VAS (pain)
EQ-5D score
MRI, X-ray and hoptests at 24 months
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline (before surgery) and at 3,6,12, and 24 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |