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

Karolinska Institute

Status: Enrolling

Conditions: Osteoarthritis Thumb

Treatments: Procedure: Platelet rich plasma (PRP); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06193499

PRP2.0

Details and patient eligibility

About

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

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Platelet rich plasma (PRP)

Active Comparator group

Description:

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

Treatment:

Procedure: Platelet rich plasma (PRP)

Placebo

Placebo Comparator group

Description:

intraarticular saline injection (0,6-1ml)

Treatment:

Other: Placebo