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

Phase 2Not Yet RecruitingNCT07491302

Goed Medisch Centrum88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Thumb Osteoarthritis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.