Department of Hand Surgery Södersjukhuset
Stockholm, S-11883, Sweden
Location status: Recruiting
Location contact
Johanna Von Kieseritzky, PhD
CONTACT
Maria Wilcke, PhD
CONTACT
NCT Number: NCT06193499
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Stockholm, S-11883, Sweden
Location status: Recruiting
Johanna Von Kieseritzky, PhD
CONTACT
Maria Wilcke, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intra-articular injection of platelet rich plasma (PRP)
Intra-articular Saline injection (0,6-1ml)
Time frame: 6 months after the first injection.
Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)
Time frame: 3 months
0-100, higher score represents more disability
Time frame: 6 months
0-100, higher score represents more disability
Time frame: 12 months
0-100, higher score represents more disability
Time frame: 3 months
0-100, lower score represents more symptoms
Time frame: 6 months
0-100, lower score represents more symptoms
Time frame: 12 months
0-100, lower score represents more symptoms
Time frame: 3 months
0-100, lower score represents more symptoms
Time frame: 6 months
0-100, lower score represents more symptoms
Time frame: 12 months
0-100, lower score represents more symptoms
Time frame: 3 months
key pinch and pinch strength (kg)
Time frame: 6 months
key pinch and pinch strength (kg)
Time frame: 12 months
key pinch and pinch strength (kg)
Time frame: 3 months
Radial and palmar abduction of the first metacarpal (degrees)
Time frame: 6 months
Radial and palmar abduction of the first metacarpal (degrees)
Time frame: 12 months
Radial and palmar abduction of the first metacarpal (degrees)
Contact information is provided by the study sponsor or research team.
Johanna VonKieseritzky, MD. PhD
CONTACT
Maria Wilcke, MD, PhD
CONTACT
Karolinska Institutet
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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