Rhizarthrosis Study

Rhizarthrosis Clinical Trial

— RHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587570
• Other study ID #: RHI01
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 8, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• diagnosed Rhizarthrosis

Exclusion Criteria:

• pregnancy and breastfeeding

• no signed Informed Consent

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

Procedure:
• Infiltration with PRP
Infiltration with 1.5 ml PRP
• Infiltration with Fat
Infiltration with 1.5 ml Fat
• Infiltration with PRP and Fat
Infiltration with 0.75 ml PRP and 0.75 ml Fat
• Infiltration with NaCl
Infiltration with 1.5 ml NaCl

Locations

Country	Name	City	State
Austria	Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.