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
Locations
Sponsors and collaborators
Goed Medisch Centrum
Lead sponsor
Arthrex, Inc.
Collaborator