ArthrosisPhase 2AMIPREP-2NCT05501743
Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).
A Phase 2 study testing Intra-articular injection of microfat and PRP and Total denervation of the wrist in people with Arthrosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthrosis
- What is being tested?
- Intra-articular injection of microfat and PRP and Total denervation of the wrist
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2023to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥ 18 years
- Patients with wrist osteoarthritis:
- Symptomatic: pain ≥ 40 mm on the visual analog scale (VAS 0-100 mm) more or less associated with a loss of strength objectified by the Jamar dynamometer and/or wrist mobility leading to discomfort in activities of daily living and impaired quality of life.
- Objectivated on radiographs and arthroscanner: stylo-scaphoid and/or global radiocarpal and/or scapho-capital and/or luno-capital joint pinch, more or less associated with osteophytic and subchondral changes equivalent to a grade 3 of the Kellgren and Lawrence classification (see chapter I). Depending on the etiology of the wrist osteoarthritis, the following may be associated: an adaptive carpal defect (DISI), a rupture of the scapholunate or pisotiquetral ligaments, a pseudarthrosis of the scaphoid, a necrosis of the proximal pole of the scaphoid, a vicious callus of the radius, or an avascular necrosis of one of the carpal bones.
- In case of failure of medical treatment for at least one year: analgesics of the appropriate level for the pain, NSAIDs, wearing of an analgesic orthosis, rehabilitation by a physiotherapist +/- intra-articular injections of corticoids or hyaluronic acid.
- Informed consent form signed by the patient
- Women of childbearing age must have a negative pregnancy test (serum or urine) (detection threshold (sensitivity): 25 mIU hCG/ml). Patients of both sexes must use reliable contraception.
- Beneficiaries or members of a social security system
Who cannot join
- Use of antiplatelet drugs, aspirin, anti vitamin K drugs less than 15 days prior to inclusion that may interfere with the quality or therapeutic effect of the investigational drug
- Chronic treatment with oral corticosteroids or less than 2 weeks old
- Intra-articular corticoid injection less than 2 months old
- Intra-articular injection of hyaluronic acid less than 2 months old
- NSAIDs taken less than 15 days ago
- Recent fever or infection (bacterial or viral) less than one month old
Show all 33Show fewer
- Current or chronic infectious diseases (viral or bacterial) as evidenced by clinical and/or biological elements (inflammatory work-up: VS, CRP, Fibrinogen)
- Autoimmune diseases attested to by questioning, or clinical and/or biological elements (inflammatory workup: VS, CRP, fibrinogen) and which may interfere with the quality or therapeutic effect of the investigational drug
- Inflammatory arthritis
- Microcrystalline arthritis
- History of surgery for the treatment of osteoarthritis of the tested wrist: total denervation of the wrist, resection of the first row of the carpus, arthrodesis, arthroplasty
- Congenital or acquired immune deficiency
- Malignant tumors under treatment or history of malignant tumors less than 5 years old
- Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical material or device (e.g. insulin pump), orthopedic medical prostheses.
- Contraindications to local anesthetics.
- Contraindications to local anesthesia or surgery
- Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. (Order of November 4, 2014 on the screening of infectious diseases during autologous therapeutic samples provided for in Article R. 1211-22-1 of the Public Health Code and amending the order of May 14, 2010 setting the content of information allowing the use of human body elements and products for therapeutic purposes)
- Body mass index (BMI) less than 18kg/m2 not allowing to obtain a sufficient quantity of adipose tissue for the manufacturing of the experimental MTI-PP and exposing the patient to a significant discomfort during the liposuction procedure
- Coagulation disorders that may interfere with the quality or therapeutic effect of the investigational drug:
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Known thrombopathy
- TP < 70% o Patient/hematopoietic ratio
- Patient to Witness APTT ratio > 1.20
- Anemia < 10g/dl contraindicating peripheral venous blood sampling
- Pregnant or breastfeeding women
- Persons of legal age (under guardianship or trusteeship)
- Persons participating simultaneously in another research project involving the human person or in a period of exclusion from a previous research project
- Persons staying in a health or social institution
- Persons in an emergency situation
- Persons deprived of liberty
- Persons who are not beneficiaries of a social security system
- Absence or refusal to give informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhône, 13354
Alexandra GIULIANI, Alexandra.GIULIANI@ap-hm.fr
About this study
Official title: Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation.
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.
Read the detailed description
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.
- Conditions
- Arthrosis
- Being tested
- Intra-articular injection of microfat and PRP, Total denervation of the wrist
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of microfat and PRPDrug
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.
Total denervation of the wristProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intra-articular injection of microfat and PRP |
| 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. Receives: Procedure: Total denervation of the wrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start17 Feb 2023
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be balanced in 2 parallel groups : * Patients in the "study treatment" group (T) will receive an intra-articular injection of microfat and PRP. * Patients in the "reference treatment" group (R) will undergo total wrist denervation surgery.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hôpitaux MarseilleAlice MAYOLY, Principal investigator, Assistance Publique Hôpitaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501743
- Sponsor's protocol ID
- 2021-006817-12
- Acronym
- AMIPREP-2
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation.
- ClinicalTrials.gov ID
- NCT05501743
- Acronym / sponsor ID
- AMIPREP-2 / 2021-006817-12
- Conditions
- Arthrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be balanced in 2 parallel groups : * Patients in the "study treatment" group (T) will receive an intra-articular injection of microfat and PRP. * Patients in the "reference treatment" group (R) will undergo total wrist denervation surgery.
| Arm | Type | Receives |
|---|---|---|
| Study treatment group (T) | Experimental | Drug: Intra-articular injection of microfat and PRPThe 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. |
| Reference treatment group (R) | Active comparator | Procedure: Total denervation of the wristThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged ≥ 18 years
- Patients with wrist osteoarthritis:
- Symptomatic: pain ≥ 40 mm on the visual analog scale (VAS 0-100 mm) more or less associated with a loss of strength objectified by the Jamar dynamometer and/or wrist mobility leading to discomfort in activities of daily living and impaired quality of life.
- Objectivated on radiographs and arthroscanner: stylo-scaphoid and/or global radiocarpal and/or scapho-capital and/or luno-capital joint pinch, more or less associated with osteophytic and subchondral changes equivalent to a grade 3 of the Kellgren and Lawrence classification (see chapter I). Depending on the etiology of the wrist osteoarthritis, the following may be associated: an adaptive carpal defect (DISI), a rupture of the scapholunate or pisotiquetral ligaments, a pseudarthrosis of the scaphoid, a necrosis of the proximal pole of the scaphoid, a vicious callus of the radius, or an avascular necrosis of one of the carpal bones.
- In case of failure of medical treatment for at least one year: analgesics of the appropriate level for the pain, NSAIDs, wearing of an analgesic orthosis, rehabilitation by a physiotherapist +/- intra-articular injections of corticoids or hyaluronic acid.
Key exclusion criteria (33 listed)
- Use of antiplatelet drugs, aspirin, anti vitamin K drugs less than 15 days prior to inclusion that may interfere with the quality or therapeutic effect of the investigational drug
- Chronic treatment with oral corticosteroids or less than 2 weeks old
- Intra-articular corticoid injection less than 2 months old
- Intra-articular injection of hyaluronic acid less than 2 months old
- NSAIDs taken less than 15 days ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular injection of microfat and PRPThe 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. | Drug | Study treatment group (T) |
| Total denervation of the wristThe 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. | Procedure or surgery | Reference treatment group (R) |
Primary outcome
Pain intensity measured on the visual analog scale (EVA)
Time frame: 6 Months
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.
8 secondary outcomes
Pain intensity measured on the visual analog scale (EVA)
Time frame: Day 7, 3 Months and 1 Year
Combined assessment of function and pain by the PRWE score
Time frame: 3 Months, 6 Months and 1 Year
Assessment of upper limb function by the DASH score
Time frame: 3 Months, 6 Months and 1 Year
Assessment of wrist strength by dynamometry
Time frame: 3 Months, 6 Months and 1 Year
Measurement of wrist joint amplitudes
Time frame: 3 Months, 6 Months and 1 Year
Overall change perceived by the patient
Time frame: 3 Months, 6 Months and 1 Year
Patient satisfaction
Time frame: Day 7, 3 Months
MRI evaluation of cartilage lesions in the "study treatment" group
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
Related trials for Arthrosis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François CREMIEUX study director
Assistance Publique Hôpitaux Marseille
Alice MAYOLY principal investigator
Assistance Publique Hôpitaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intra-articular injection of microfat and PRP and Total denervation of the wrist in people with Arthrosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice MAYOLY (0413429283, alice.mayoly@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured on the visual analog scale (EVA) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.