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

Not Applicable

Completed

• Conditions: Thumb Osteoarthritis
• Interventions: Other: Placebo; Other: PRP

• Registration Number: NCT04218591
• Lead Sponsor: Karolinska Institutet

Brief Summary

Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2020-02-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Arthritis 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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Placebo	Intra-articular injection Saline
PRP	PRP	Intra-articular injection PRP

Primary Outcome Measures

Name	Time	Method
Change in patient-rated pain on load	3 and 6 months after injection.	Numerical rating scale 0-10p (10=worst possible pain).

Secondary Outcome Measures

Name	Time	Method
Change in Nelson Thumb score	3 and 6 months after injection.	Patient Rated Outcome Measure, 0-100p, lower score= more disability
Change in Patient-rated Wrist and Hand Evaluation (PRWHE)	3 and 6 months after injection.	Patient Rated Outcome Measure 0-100p, higher score=more disability
Change in Disability of the Hand, Arm and Shoulder (DASH) score	3 and 6 months after injection.	Patient Rated Outcome Measure, 0-100p higher score=more disability
Change in Pain Catastrophizing Score (PCS).	3 and 6 months after injection.	0-52p, higher score = more pain catastrophizing
Change in thumb strength	3 and 6 months after injection.	Key pinch and pinch strength (Kg)
Change in Hospital Anxiety and Depression Score (HADS),	3 and 6 months after injection.	2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse
Change in thumb range of motion	3 and 6 months after injection.	Radial and palmar abduction of the first metacarpal (degrees)
Change in EQ-5D	3 and 6 months after injection.	Weight mean value: 0=dead, 1= healthy

Trial Locations

Locations (1)

Department of Hand Surgery Södersjukhuset; 🇸🇪 Stockholm, Sweden