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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGoed Medisch Centrum

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Platelet-Rich Plasma (PRP) Injections
  • Saline (0.9% NaCl)

Treatment groups

88 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Goed Medisch Centrum

Lead sponsor

Arthrex, Inc.

Collaborator