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

NCT06193499 | Recruiting

• 1 other identifier: PRP2.0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis Thumb

Keywords

CMC-1 joint; thumb basal joint; PRP; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Pain on load in thumb

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

  6 months after the first injection.

Secondary Outcomes (15)

• Patient-rated Wrist and Hand (PRWHE) score

  3 months

• Patient-rated Wrist and Hand (PRWHE) score

  6 months

• Patient-rated Wrist and Hand (PRWHE) score

  12 months

• Nelson thumb score

  3 months

• Nelson thumb score

  6 months

Study Arms (2)

Platelet rich plasma (PRP)

ACTIVE COMPARATOR

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

Procedure: Platelet rich plasma (PRP)

Placebo

PLACEBO COMPARATOR

intraarticular saline injection (0,6-1ml)

Other: Placebo

Interventions

Platelet rich plasma (PRP) PROCEDURE

Intra-articular injection of platelet rich plasma (PRP)

Platelet rich plasma (PRP)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Hand Surgery Södersjukhuset

Stockholm, S-11883, Sweden

RECRUITING

Related Publications (1)

• von Kieseritzky J, Wilcke M. High-concentrated platelet-rich plasma (PRP) versus placebo in osteoarthritis in the thumb base: study protocol for an assessor-blinded randomized controlled trial. Trials. 2024 Nov 26;25(1):797. doi: 10.1186/s13063-024-08636-2.

  PMID: 39587622 DERIVED

Central Study Contacts

Maria Wilcke, MD, PhD

CONTACT

+46708294613; maria.wilcke@regionstockholm.se

Johanna VonKieseritzky, MD. PhD

CONTACT

johanna.vonkieseritzky@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: blind fold on participants. No infomration about given treatment to outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate profesoor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)