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

August 5, 2026 updated by: Maria Wilcke, Karolinska Institutet
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-11883
        • Department of Hand Surgery Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

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)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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