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NCT07491302
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Conditions: Thumb Osteoarthritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 88
Sponsor: Goed Medisch Centrum
Location: GOED Medisch Centrum Breda North Brabant
Summary
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
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
Source: ClinicalTrials.gov (NCT07491302). StuddyBuddy aggregates publicly available trial information.