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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis Thumb
• Intervention / Treatment: Procedure: Platelet rich plasma (PRP); Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Wilcke, MD, PhD; Phone Number: +46708294613; Email: maria.wilcke@regionstockholm.se
• Study Contact Backup: Name: Johanna VonKieseritzky, MD. PhD; Email: johanna.vonkieseritzky@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden, S-11883
    • Recruiting
    • Department of Hand Surgery Södersjukhuset
    • Contact: Maria Wilcke, PhD; Phone Number: +46708294613; Email: maria.wilcke@regionstockholm.se
    • Contact: Johanna Von Kieseritzky, PhD; Email: johanna.vonkieseritzky@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet rich plasma (PRP); High-concentration PRP injection PRP injection (0,6-1ml). Arthrex ACPmax system.	Procedure: Platelet rich plasma (PRP); Intra-articular injection of platelet rich plasma (PRP)
Placebo Comparator: Placebo; intraarticular saline injection (0,6-1ml)	Other: Placebo; Intra-articular Saline injection (0,6-1ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	3 months
Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	6 months
Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	12 months
Nelson thumb score	0-100, lower score represents more symptoms	3 months
Nelson thumb score	0-100, lower score represents more symptoms	6 months
Nelson thumb score	0-100, lower score represents more symptoms	12 months
HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	3 months
HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	6 months
HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	12 months
key pinch and pinch strength	key pinch and pinch strength (kg)	3 months
key pinch and pinch strength	key pinch and pinch strength (kg)	6 months
key pinch and pinch strength	key pinch and pinch strength (kg)	12 months
Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	3 months
Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	6 months
Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	12 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: PRP; Platelet-rich plasma; CMC-1 joint; thumb basal joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: PRP2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No