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Rhizarthrosis Study

NCT04587570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-11-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Lars-Peter Kamolz, Univ. Prof. Dr. · Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery

  • Raimund Winter, Dr. · Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2021-03-01
Completion
2021-11-08

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587570 on ClinicalTrials.gov