A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

NCT ID: NCT04218591

Last Updated: 2024-01-19

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2023-12-31

Brief Summary

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Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

Detailed Description

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Conditions

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Thumb Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PRP

Intra-articular injection PRP

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type OTHER

Platelet rich plasma

Saline

Intra-articular injection Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Interventions

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PRP

Platelet rich plasma

Intervention Type OTHER

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Arthritis in the thumb base.
* Radiological Eaton Littler class 1-3.
* Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

Exclusion Criteria

* Rheumatoid arthritis.
* Ongoing infection in the hand or wrist.
* History of gout or pseudo gout.
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (STT joint involved).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Maria Wilcke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Wilcke, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Department of Hand Surgery Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PRP vs placebo

Identifier Type: -

Identifier Source: org_study_id

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