Rhizarthrosis
Conditions
Keywords
Rhizarthrosis
Brief summary
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.
Interventions
PROCEDUREInfiltration with PRP
Infiltration with 1.5 ml PRP
PROCEDUREInfiltration with Fat
Infiltration with 1.5 ml Fat
PROCEDUREInfiltration with PRP and Fat
Infiltration with 0.75 ml PRP and 0.75 ml Fat
PROCEDUREInfiltration with NaCl
Infiltration with 1.5 ml NaCl
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed Rhizarthrosis
Exclusion criteria
* pregnancy and breastfeeding * no signed Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perception of pain sensation in the thumb saddle joint | is measured 5 times, from screening visit to 3 months after intervention | assessed by VAS (Visual Analogue scale). The range goes from 0 (no pain) to 10 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mobility of the thumb | is measured 5 times, from screening visit to 3 months after intervention. | 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. |
| Change in quality of life score, assessed by Questionnaire SF36 | is measured 5 times, from screening visit to 3 months after intervention. | 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 |
| Change in force in the thumb saddle joint. | is measured 5 times, from screening visit to 3 months after intervention. | Evaluated by dynamometer: tweezergrip with Pinch-Gauge-Dynamometer, Crossgrip with Jamar-Dynamometer |
| Change in Michigan Hand Outcomes Questionnaire (MHQ) | is measured 5 times, from screening visit to 3 months after intervention. | 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. |
| Change in movement in the thumb saddle joint. | is measured 5 times, from screening visit to 3 months after intervention. | lateralgrip of dump and index finger |
| Change in Disabilities of Arm, Shoulder and Hand (DASH) Score | is measured 5 times, from screening visit to 3 months after intervention. | Upper-extremity disability and symptoms are assessed by the DASH-Score. The range goes from 0 (no disability) to 100. |
Countries
Austria
Outcome results
None listed