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Rhizarthrosis Study

NCT ID: NCT04587570

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2021-11-08

Brief Summary

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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.

Detailed Description

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Conditions

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Rhizarthrosis

Keywords

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Rhizarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1: Infiltration of PRP

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

Group Type EXPERIMENTAL

Infiltration with PRP

Intervention Type PROCEDURE

Infiltration with 1.5 ml PRP

Group 2: Infiltration of Fat

The proband gets fat injected in the thumb saddle joint.

Group Type EXPERIMENTAL

Infiltration with Fat

Intervention Type PROCEDURE

Infiltration with 1.5 ml Fat

Group 3: Infiltration of PRP and Fat

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

Group Type EXPERIMENTAL

Infiltration with PRP and Fat

Intervention Type PROCEDURE

Infiltration with 0.75 ml PRP and 0.75 ml Fat

Group 4: Infiltration of NaCl

The proband gets NaCl injected in the thumb saddle joint.

Group Type PLACEBO_COMPARATOR

Infiltration with NaCl

Intervention Type PROCEDURE

Infiltration with 1.5 ml NaCl

Interventions

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Infiltration with PRP

Infiltration with 1.5 ml PRP

Intervention Type PROCEDURE

Infiltration with Fat

Infiltration with 1.5 ml Fat

Intervention Type PROCEDURE

Infiltration with PRP and Fat

Infiltration with 0.75 ml PRP and 0.75 ml Fat

Intervention Type PROCEDURE

Infiltration with NaCl

Infiltration with 1.5 ml NaCl

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosed Rhizarthrosis

Exclusion Criteria

* pregnancy and breastfeeding
* no signed Informed Consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars-Peter Kamolz, Univ. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery

Raimund Winter, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery

Locations

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Medical University Graz, Department of Plastic, Aesthetic and Reconstructive Surgery Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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RHI01

Identifier Type: -

Identifier Source: org_study_id