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

N/ARecruitingNCT06193499

Karolinska Institutet90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis Thumb

Interventions

Platelet rich plasma (PRP)PROCEDURE

Intra-articular injection of platelet rich plasma (PRP)

PlaceboOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Locations (1)

Department of Hand Surgery Södersjukhuset

Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

Pain on load in thumb

Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)

Time frame: 6 months after the first injection.

Secondary Outcomes

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame: 3 months

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame: 6 months

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame: 12 months

Nelson thumb score