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

NCT07491302 | Not Yet Recruiting Phase 2

• 1 other identifier: NL-010929
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

platelet-rich plasma; CMC-I joint; carpometacarpal joint osteoarthritis; Thumb base osteoarthritis; PRP injection; Placebo-controlled trial; Orthobiologics; Regenerative medicine; Ultrasound-guided injection

Outcome Measures

Primary Outcomes (1)

• 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.

  3, 6, 9 and 12 months

Secondary Outcomes (4)

• Functional improvement: Michigan Hand Outcomes Questionnaire (MHQ-DLV)

  3, 6, 9 and 12 months

• Functional improvement: Grip and pinch test

  3, 6, 9 and 12 months

• Functional improvement: Opposition of the thumb (pollexograph)

  3, 6, 9 and 12 months

• Functional improvement: Kapandji Opposition Score

  3, 6, 9 and 12 months

Study Arms (2)

Platelet-rich plasma group A

EXPERIMENTAL

Biological: Platelet-Rich Plasma (PRP) Injections

Placebo group B

PLACEBO COMPARATOR

Saline

Drug: Saline (0.9% NaCl)

Interventions

Platelet-Rich Plasma (PRP) Injections BIOLOGICAL

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.

Platelet-rich plasma group A

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.

Also known as: Placebo injection

Placebo group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Smoking
• Active use of statins

Sponsors & Collaborators

• Goed Medisch Centrum: lead
• Arthrex, Inc.: collaborator

MeSH Terms

Interventions

Injections; Sodium Chloride

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03