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

Thumb Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218591
• Other study ID #: PRP vs placebo
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Other:
• PRP
Platelet rich plasma
• Placebo
Saline

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	Change in patient-rated pain on load	Numerical rating scale 0-10p (10=worst possible pain).	3 and 6 months after injection.
Secondary	Change in Nelson Thumb score	Patient Rated Outcome Measure, 0-100p, lower score= more disability	3 and 6 months after injection.
Secondary	Change in EQ-5D	Weight mean value: 0=dead, 1= healthy	3 and 6 months after injection.
Secondary	Change in Patient-rated Wrist and Hand Evaluation (PRWHE)	Patient Rated Outcome Measure 0-100p, higher score=more disability	3 and 6 months after injection.
Secondary	Change in Disability of the Hand, Arm and Shoulder (DASH) score	Patient Rated Outcome Measure, 0-100p higher score=more disability	3 and 6 months after injection.
Secondary	Change in Hospital Anxiety and Depression Score (HADS),	2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse	3 and 6 months after injection.
Secondary	Change in Pain Catastrophizing Score (PCS).	0-52p, higher score = more pain catastrophizing	3 and 6 months after injection.
Secondary	Change in thumb range of motion	Radial and palmar abduction of the first metacarpal (degrees)	3 and 6 months after injection.
Secondary	Change in thumb strength	Key pinch and pinch strength (Kg)	3 and 6 months after injection.