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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2027-06-30

Brief Summary

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This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.

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Detailed Description

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The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.

Conditions

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Osteoarthritis Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

blind fold on participants. No infomration about given treatment to outcome assessors.

Study Groups

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Platelet rich plasma (PRP)

High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system.

Group Type ACTIVE_COMPARATOR

Platelet rich plasma (PRP)

Intervention Type PROCEDURE

Intra-articular injection of platelet rich plasma (PRP)

Placebo

intraarticular saline injection (0,6-1ml)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intra-articular Saline injection (0,6-1ml)

Interventions

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Platelet rich plasma (PRP)

Intra-articular injection of platelet rich plasma (PRP)

Intervention Type PROCEDURE

Placebo

Intra-articular Saline injection (0,6-1ml)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis 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 pseudogout in the hand
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Chronic pain syndrome / centralized pain.
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (symptomatic STT joint osteoarthritis).

Eligible Sex

ALL

Accepts Healthy Volunteers

No