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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment group (T) | Experimental | 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. |
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| Reference treatment group (R) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular injection of microfat and PRP | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7, 3 Months and 1 Year |
| Combined assessment of function and pain by the PRWE score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice MAYOLY | Contact | 0413429283 | alice.mayoly@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | Assistance Publique Hôpitaux Marseille | Study Director |
| Alice MAYOLY | Assistance Publique Hôpitaux Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux Marseille | Recruiting | Marseille | Bouches-du-Rhône | 13354 | France |
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Randomization will be balanced in 2 parallel groups :
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| Total denervation of the wrist | Procedure | 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. |
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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. |
| 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). | 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. | 3 Months, 6 Months and 1 Year |
| Measurement of wrist joint amplitudes | The joint amplitudes of the wrist will be measured with a goniometer :
| 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). | 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. | 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. | 6 Months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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