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NCT Number: NCT06193499

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Platelet Rich Plasma (PRP)

Procedure

Intra-articular injection of platelet rich plasma (PRP)

Placebo

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Patient-rated Wrist and Hand (PRWHE) score

    Time frame: 3 months

    0-100, higher score represents more disability

  2. Patient-rated Wrist and Hand (PRWHE) score

    Time frame: 6 months

    0-100, higher score represents more disability

  3. Patient-rated Wrist and Hand (PRWHE) score

    Time frame: 12 months

    0-100, higher score represents more disability

  4. Nelson thumb score

    Time frame: 3 months

    0-100, lower score represents more symptoms

  5. Nelson thumb score

    Time frame: 6 months

    0-100, lower score represents more symptoms

  6. Nelson thumb score

    Time frame: 12 months

    0-100, lower score represents more symptoms

  7. HAKIR symptom score (HQ-8)

    Time frame: 3 months

    0-100, lower score represents more symptoms

  8. HAKIR symptom score (HQ-8)

    Time frame: 6 months

    0-100, lower score represents more symptoms

  9. HAKIR symptom score (HQ-8)

    Time frame: 12 months

    0-100, lower score represents more symptoms

  10. key pinch and pinch strength

    Time frame: 3 months

    key pinch and pinch strength (kg)

  11. key pinch and pinch strength

    Time frame: 6 months

    key pinch and pinch strength (kg)

  12. key pinch and pinch strength

    Time frame: 12 months

    key pinch and pinch strength (kg)

  13. Radial and palmar abduction

    Time frame: 3 months

    Radial and palmar abduction of the first metacarpal (degrees)

  14. Radial and palmar abduction

    Time frame: 6 months

    Radial and palmar abduction of the first metacarpal (degrees)

  15. Radial and palmar abduction

    Time frame: 12 months

    Radial and palmar abduction of the first metacarpal (degrees)

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna VonKieseritzky, MD. PhD

CONTACT

[email protected]

Maria Wilcke, MD, PhD

CONTACT

[email protected]

+46708294613

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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