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

Not Applicable

Recruiting

• Conditions: Osteoarthritis Thumb
• Interventions: Other: Placebo; Procedure: Platelet rich plasma (PRP)

• Registration Number: NCT06193499
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-20
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-05
• Study Start: 2024-01-17
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	intraarticular saline injection (0,6-1ml)
Platelet rich plasma (PRP)	Platelet rich plasma (PRP)	High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system.

Primary Outcome Measures

Name	Time	Method
Pain on load in thumb	6 months after the first injection.	Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)

Secondary Outcome Measures

Name	Time	Method
HAKIR symptom score (HQ-8)	12 months	0-100, lower score represents more symptoms
Nelson thumb score	12 months	0-100, lower score represents more symptoms
key pinch and pinch strength	12 months	key pinch and pinch strength (kg)
Radial and palmar abduction	12 months	Radial and palmar abduction of the first metacarpal (degrees)
Patient-rated Wrist and Hand (PRWHE) score	12 months	0-100, higher score represents more disability

Trial Locations

Locations (1)

Department of Hand Surgery Södersjukhuset; 🇸🇪 Stockholm, Sweden