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NCT Number: NCT07491302

Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection

The goal of this clinical trial is to evaluate whether platelet-rich plasma (PRP) injections improve pain and function in adults with thumb base osteoarthritis (CMC-I OA).

The main questions it aims to answer are:

Does a PRP injection reduce pain compared to a placebo (saline) injection? Does PRP improve hand function, strength, and thumb mobility? What adverse events occur following PRP treatment?

Researchers will compare PRP injections to a placebo injection (saline solution) to determine whether PRP is an effective treatment for CMC-I osteoarthritis.

Participants will:

Receive a single ultrasound-guided injection of PRP or placebo (saline) in the CMC-I joint.

Attend follow-up visits at 3, 6, 9, and 12 months for clinical assessments. Complete questionnaires on pain (VAS) and hand function (MHQ-DLV) at multiple time points.

Undergo physical examinations (grip strength, pinch strength, thumb motion). Undergo ultrasound evaluations to assess joint characteristics.

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Key information

Conditions

Thumb Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Patients with an Eaton-littler score of I, II or III
  • Patients with uni- or bilateral CMC-I osteoarthritis
  • Non-responders to conservative therapy i.e., hand therapy and immobilisation after 3 months

Exclusion criteria

  • Aged below 18
  • Patients with an Eaton-littler score of IV (STT arthrosis)
  • Surgical interventions of the CMC-I joint
  • A known articular systemic disease (e.g. rheumatoid arthritis) or additional hand osteoarthritis/ tenosynovitis or metabolic disease like diabetes mellitus
  • Patients with an infectious arthritis of CMC-I joint
  • A known psychiatric condition
  • Neuropathic chronic pain syndrome
  • Intra articular injection 6 months prior to inclusion
  • Smoking
  • Active use of statins

Treatment and study plan

Platelet-Rich Plasma (PRP) Injections

Biological

Autologous platelet-rich plasma (PRP) is prepared from 90 mL of the participant's venous blood using a standardized two-step centrifugation protocol (ACP® Max system, Arthrex Inc.). The first centrifugation is performed at 3200 rpm for 9 minutes, followed by a second centrifugation at 1500 rpm for 5 minutes, resulting in approximately 2 mL of PRP. A single injection of 2 mL PRP is administered under sterile conditions and ultrasound guidance into the CMC-I joint, consisting of 1 mL intra-articular and 1 mL peri-articular injection. No repeated injections are performed.

Saline (0.9% NaCl)

Drug

Participants receive a placebo injection consisting of 2 mL sterile saline (0.9% NaCl), administered under sterile conditions and ultrasound guidance into the CMC-I joint. The injection protocol is identical to the PRP group, with 1 mL injected intra-articularly and 1 mL peri-articularly. To maintain blinding, participants in the placebo group undergo a venous blood draw mimicking the PRP preparation procedure; however, the collected blood is discarded. The duration and procedural steps are standardized to ensure comparable treatment conditions between groups. No repeated injections are performed.

Other names: Placebo injection

Primary outcomes

  1. Clinical pain improvement: Visual Analog Scale (VAS) for pain

    Time frame: 3, 6, 9 and 12 months

    Pain will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 indicates no pain and 100 indicates worst imaginable pain. A decrease in VAS score reflects an improvement in pain.

Secondary outcomes

  1. Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV)

    Time frame: 3, 6, 9 and 12 months

    Hand function will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ), Dutch Language Version (MHQ-DLV). The MHQ is a patient-reported outcome measure consisting of multiple domains (including overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction), each scored on a scale from 0 to 100. For all domains except pain, higher scores indicate better hand function and greater satisfaction. For the pain domain, higher scores indicate more severe pain.

  2. Functional improvement: Grip and pinch test

    Time frame: 3, 6, 9 and 12 months

  3. Functional improvement: Opposition of the thumb (pollexograph)

    Time frame: 3, 6, 9 and 12 months

  4. Functional improvement: Kapandji Opposition Score

    Time frame: 3, 6, 9 and 12 months

    Thumb opposition will be assessed using the Kapandji Opposition Score, a clinical scale ranging from 0 to 10, where 0 indicates no opposition and 10 indicates maximal opposition of the thumb across the palm. Higher scores indicate better thumb function and greater range of opposition.

Sponsors and collaborators

Lead sponsor

Goed Medisch Centrum

Other

Collaborators

  • Arthrex, Inc.

Registry information

Official study title

Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection (Thumbs-up Study)

Acronym: Thumbs-up

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Apr 9, 2026

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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