A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.

Osteoarthritis Thumb Clinical Trial

Official title:

A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193499
• Other study ID #: PRP2.0
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: Maria Wilcke, MD, PhD
• Phone: +46708294613
• Email: maria.wilcke[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.

Description:

The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Osteoarthritis in the thumb base
• Radiological Eaton Littler class 1-3.
• Clinical signs of thumb base osteoarthritis )pain at palpation of the CMC-1 joint and pain during provocation/grinding test).

Exclusion Criteria:

• Rheumatoid arthritis
• Ongoing infection in the hand or wrist
• History of gout or pseudogout in the hand
• Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
• Chronic pain syndrome / centralized pain.
• Intra-articular injection in the affected joint within 6 months.
• Eaton Littler class 4 (symptomatic STT joint osteoarthritis).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Thumb

Intervention

Procedure:
• Platelet rich plasma (PRP)
Intra-articular injection of platelet rich plasma (PRP)

Other:
• Placebo
Intra-articular Saline injection (0,6-1ml)

Locations

Country	Name	City	State
Sweden	Department of Hand Surgery Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on load in thumb	Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)	6 months after the first injection.
Secondary	Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	3 months
Secondary	Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	6 months
Secondary	Patient-rated Wrist and Hand (PRWHE) score	0-100, higher score represents more disability	12 months
Secondary	Nelson thumb score	0-100, lower score represents more symptoms	3 months
Secondary	Nelson thumb score	0-100, lower score represents more symptoms	6 months
Secondary	Nelson thumb score	0-100, lower score represents more symptoms	12 months
Secondary	HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	3 months
Secondary	HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	6 months
Secondary	HAKIR symptom score (HQ-8)	0-100, lower score represents more symptoms	12 months
Secondary	key pinch and pinch strength	key pinch and pinch strength (kg)	3 months
Secondary	key pinch and pinch strength	key pinch and pinch strength (kg)	6 months
Secondary	key pinch and pinch strength	key pinch and pinch strength (kg)	12 months
Secondary	Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	3 months
Secondary	Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	6 months
Secondary	Radial and palmar abduction	Radial and palmar abduction of the first metacarpal (degrees)	12 months