Rhizarthrosis Study

Study Overview
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Brief Summary
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Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up to 25% of postmenopausal women. There are currently various conservative and surgical methods available for treatment. If conservative treatment does not lead to freedom from pain, one of the surgical methods can be used, such as metacarpal extension osteotomy, trapeziectomy with or without ligamentoplasty, trapeziometacarpal arthrodesis, prosthesis implantation and various forms of interposition arthroplasty . Despite the high satisfaction rate of up to 95% after surgical treatment, the anatomy of the carpus is irreversibly destroyed . Apart from that, these operations are also associated with corresponding complications and post-operative immobilization of several weeks. Thus, a minimally invasive treatment method with a corresponding success rate would be of great advantage. Hypothesis: By infiltrating and filling the joint with Platelet-Rich Plasma (PRP), fat or a combination of both, the pain of rhizarthrosis can be reduced. Aim of the study: The aim of the announced doctoral thesis is to investigate the effect of PRP, lipofilling and its combination on arthroses of the thumb saddle joint after a single joint injection and to compare it with a control group.It is to be proven that PRP, fat and their combination lead to a different degree of pain relief compared to the control group due to the expansion of the joint space and the associated filling effect.

Official Title
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Injection of Platelet Rich Plasma and Autologous Fat Into the Thumb Carpometacarpal Joint for the Evaluation Their Potential Filling Effect in Patients With Osteoarthritis

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Procedure: Infiltration with PRP
* Procedure: Infiltration with Fat
* Procedure: Infiltration with PRP and Fat
* Procedure: Infiltration with NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed Rhizarthrosis Exclusion Criteria: pregnancy and breastfeeding no signed Informed Consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Infiltration of PRP<br>The proband gets Platelet Rich Plasma injected in the thumb saddle joint. | Procedure: Infiltration with PRP<br>* Infiltration with 1.5 ml PRP<br>|
| Experimental: Group 2: Infiltration of Fat<br>The proband gets fat injected in the thumb saddle joint. | Procedure: Infiltration with Fat<br>* Infiltration with 1.5 ml Fat<br>|
| Experimental: Group 3: Infiltration of PRP and Fat<br>The proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint. | Procedure: Infiltration with PRP and Fat<br>* Infiltration with 0.75 ml PRP and 0.75 ml Fat<br>|
| Placebo Comparator: Group 4: Infiltration of NaCl<br>The proband gets NaCl injected in the thumb saddle joint. | Procedure: Infiltration with NaCl<br>* Infiltration with 1.5 ml NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perception of pain sensation in the thumb saddle joint | assessed by VAS (Visual Analogue scale). The range goes from 0 (no pain) to 10 (worst imaginable pain). | is measured 5 times, from screening visit to 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in force in the thumb saddle joint. | Evaluated by dynamometer: tweezergrip with Pinch-Gauge-Dynamometer, Crossgrip with Jamar-Dynamometer | is measured 5 times, from screening visit to 3 months after intervention. | 
| Change in mobility of the thumb | assessed by Kapandji-score, measured degrees of motion Dig I MCP, Dig I IP. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition. | is measured 5 times, from screening visit to 3 months after intervention. | 
| Change in quality of life score, assessed by Questionnaire SF36 | The SF36 consists of 8 domains, the range of every scale goes from 0-100. A higher score indicates no restriction in health. 0 =greatest possible restriction of health; 100 = absence of health restrictions | is measured 5 times, from screening visit to 3 months after intervention. | 
| Change in Disabilities of Arm, Shoulder and Hand (DASH) Score | Upper-extremity disability and symptoms are assessed by the DASH-Score. The range goes from 0 (no disability) to 100. | is measured 5 times, from screening visit to 3 months after intervention. | 
| Change in Michigan Hand Outcomes Questionnaire (MHQ) | The MHQ has six domains. Overall hand function, activities of daily living (ADLs), work performance, aesthetics, and patient satisfaction) are scored from 0 - 100 in which 100 is the best possible ability. The pain domain is scored from 0 - 100, where 0 indicates no pain. | is measured 5 times, from screening visit to 3 months after intervention. | 
| Change in movement in the thumb saddle joint. | lateralgrip of dump and index finger | is measured 5 times, from screening visit to 3 months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhizarthrosis