NCT07491302

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Goed Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thumb Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Platelet-Rich Plasma (PRP) Injections	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.
DRUG	Saline (0.9% NaCl)	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2026-03-24
• Last updated: 2026-04-09