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

Goed Medisch Centrum

Status and phase: Not yet enrolling; Phase 2

Conditions: Thumb Osteoarthritis

Treatments: Drug: Saline (0.9% NaCl); Biological: Platelet-Rich Plasma (PRP) Injections

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07491302

NL-010929

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Platelet-rich plasma group A

Experimental group

Treatment:

Biological: Platelet-Rich Plasma (PRP) Injections

Placebo group B

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline (0.9% NaCl)