NCT04587570

Rhizarthrosis Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhizarthrosis

Interventions

Type	Name	Description
PROCEDURE	Infiltration with PRP	Infiltration with 1.5 ml PRP
PROCEDURE	Infiltration with Fat	Infiltration with 1.5 ml Fat
PROCEDURE	Infiltration with PRP and Fat	Infiltration with 0.75 ml PRP and 0.75 ml Fat
PROCEDURE	Infiltration with NaCl	Infiltration with 1.5 ml NaCl

Timeline

• Start date: 2017-05-22
• Primary completion: 2021-03-01
• Completion: 2021-11-08
• First posted: 2020-10-14
• Last updated: 2021-11-09

Locations

1 site across 1 country: Austria