Rhizarthrosis Study (RHI)

Medical University of Graz

Status: Completed

Conditions: Rhizarthrosis

Treatments: Procedure: Infiltration with PRP and Fat; Procedure: Infiltration with Fat; Procedure: Infiltration with NaCl; Procedure: Infiltration with PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT04587570

RHI01

Details and patient eligibility

About

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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed Rhizarthrosis

Exclusion criteria

• pregnancy and breastfeeding
• no signed Informed Consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 4 patient groups, including a placebo group

Group 1: Infiltration of PRP

Experimental group

Description:

The proband gets Platelet Rich Plasma injected in the thumb saddle joint.

Treatment:

Procedure: Infiltration with PRP

Group 2: Infiltration of Fat

Experimental group

Description:

The proband gets fat injected in the thumb saddle joint.

Treatment:

Procedure: Infiltration with Fat

Group 3: Infiltration of PRP and Fat

Experimental group

Description:

The proband gets a mixture of Platelet Rich Plasma (PRP) and Fat injected in the thumb saddle joint.

Treatment:

Procedure: Infiltration with PRP and Fat

Group 4: Infiltration of NaCl

Placebo Comparator group

Description:

The proband gets NaCl injected in the thumb saddle joint.

Treatment:

Procedure: Infiltration with NaCl