This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial. It is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.
The main objective is to demonstrate the non-inferiority of the efficacy of intra-articular injection of autologous microfat and PRP in patients suffering from radiocarpal osteoarthritis resistant to medical treatment on pain evaluated by the visual analog scale (VAS) at 6 months in comparison with total denervation of the wrist (reference treatment). Secondary objectives are: * To assess the safety of the study treatment at D7, M3, M6, M12, compared to the reference treatment group: Adverse events and post-operative follow-up data. * To assess the non-inferiority of the study treatment compared to the reference treatment on the secondary efficacy criteria. * Evaluate the effectiveness of the treatment under study. * Evaluate patient satisfaction. * To investigate the existence of a relationship between the characteristics of the injected products and the clinical improvement and to describe the characteristics of the responder and non-responder patients. The responder patient was characterized by an improvement of the VAS at 6 months superior to the minimal clinically significant difference fixed at 14 points. * To evaluate the improvement of cartilage relaxation time on high-resolution T2 gradient echo and Turbo Spin Echo 3T MRI sequences at 6 months in patients in the "study treatment" group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
The treatment by intra-articular injection of autologous microfat and PRP will be performed during a half-day outpatient stay in the hand and limb repair surgery department at the Hôpital de la Timone. The total duration of the procedure is approximately 4 hours and includes 2 surgical times performed in the operating room and an intermediate waiting time for the patient in an outpatient room during the preparation of the experimental products.
The surgical treatment by total denervation of the wrist will be performed during a one-day outpatient stay in the hand and limb surgery department at the Hôpital de la Timone. It will be performed under loco-regional anesthesia by axillary plexus block.
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhône, France
RECRUITINGPain intensity measured on the visual analog scale (EVA)
The patient will indicate his or her pain using a cross on a 10 cm scale called the VAS score. The VAS is rated from 0 to 100 by the evaluator. The higher the patient's score, the greater the pain.
Time frame: 6 Months
Pain intensity measured on the visual analog scale (EVA)
The patient will indicate his or her pain using a cross on a 10 cm scale called the VAS score. The VAS is rated from 0 to 100 by the evaluator. The higher the patient's score, the greater the pain.
Time frame: Day 7, 3 Months and 1 Year
Combined assessment of function and pain by the PRWE score
The PRWE (Patient-Rated Wrist Evaluation) is a specific wrist function and pain assessment score. The questionnaire consists of 15 items, 5 of which focus on pain (50 points) and 10 on wrist function (100 points). We will use the combined score in which the total points for wrist function are divided by 2 and added to the pain score to obtain a total score out of 100 points.
Time frame: 3 Months, 6 Months and 1 Year
Assessment of upper limb function by the DASH score
The DASH (Disabilities of the Arm, Shoulder and Hand) is a subjective self-assessment questionnaire of the overall functional capacity of both upper limbs. The questionnaire consists of 30 questions covering difficulty with specific activities of daily living, social relationships, and specific symptoms: pain, strength, mobility and sleep. The overall score is presented as a score out of 100 by the following calculation method: \[(sum of n responses)-1\] x 25n. The score is only valid if 90% of the questions have been filled in by the patient (i.e. 3 missing values at most).
Time frame: 3 Months, 6 Months and 1 Year
Assessment of wrist strength by dynamometry
Wrist grip strength will be assessed by the average score of 3 consecutive measurements on the Jamar hydraulic hand dynamometer.
Time frame: 3 Months, 6 Months and 1 Year
Measurement of wrist joint amplitudes
The joint amplitudes of the wrist will be measured with a goniometer : * in radial tilt * in ulnar tilt * in flexion * in extension These measurements are noted for the wrist with osteoarthritis and the contralateral wrist.
Time frame: 3 Months, 6 Months and 1 Year
Overall change perceived by the patient
The patient's overall perceived change will be assessed using the 7-level Likert scale (Check the box that best describes the current condition of your wrist, compared to before the procedure." Much better, Better, Slightly better, No change, Slightly worse, Worse, Much worse).
Time frame: 3 Months, 6 Months and 1 Year
Patient satisfaction
The patient will answer using the 3-level Likert scale if he/she is satisfied with the therapeutic procedure (Denervation or intra-articular injection of the product under study) ("Check the box that best describes your level of satisfaction with the intervention." (satisfied vs. neither satisfied-nor dissatisfied or dissatisfied; improved vs. no change or worse)The patient will also be asked if he/she would recommend this procedure to a loved one.
Time frame: Day 7, 3 Months
MRI evaluation of cartilage lesions in the "study treatment" group
Pre- and post-operative MRI analysis in the "study treatment" group will allow quantitative assessment of the variation in cartilage relaxation time on gradient echo and 3D high-resolution 3T MRI sequences.
Time frame: 6 Months
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