E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic radio-carpal osteoarthritis |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 |
Evaluate the safety at 1 month of intra-articular injection of microfat associated with PRP in the radio-carpal joint of patients with radiocarpal osteoarthritis. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the following efficiency criteria:
at 3,6, 12 months : -Improvement of pain with the Visual Analogue Scale (VAS). -Improvement of wrist pain and function with DASH and PWRE scores. -Improvement of wrist range of motion -Improvement of Jamar strength test -Patient satisfaction
at 12 months : -Improvement of radiocarpal chondral lesions on specific MRI sequences
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males and females between 20 and 75 years of age -Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery -BMI ≥ 20 Kg/m² -Written informed consent, signed by patient or legal representative (if patient unable to sign). -HB > 10g/dl -Negative pregnancy test and efficiency contraception
|
|
E.4 | Principal exclusion criteria |
-Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy -TP < 70%, TCA patient / witness rapport > 1,20 -Anemia: HB < 10g/dl -Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA -Treatment by platelet inhibiting agent, aspirin, antivitamin K completed more than 2 weeks before inclusion -Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion -Intra articular injection of corticosteroid or hyaluronic acid completed more than 8 weeks before inclusion -NSAI treatment completed more than 2 weeks before inclusion -Fever or recent disease completed more than 1 month before inclusion -Auto immune disease, Inflammatory or microcrystalline Arthritis, Immune deficit -Infectious disease -IRM contraindication: ocular loose bodies, pace maker, neurostimulator, cochlear implant, vascular clips, metallic cardiac val -Anesthesia or surgery contra indication, iodine allergy
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
tolerance assessed by the occurrence of adverse events up to one month post administration related to study treatments according to their origin : - Related AEs adipose tissue removal - AE related to the production of PRP and preparation of micrograisse - AE related to intra-articular injection |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Pain assessment -Assessment of wrist strength by dynamometry |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |