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

ConditionOsteoarthritis Thumb
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet rich plasma (PRP)

    Procedure/Surgery

    Intra-articular injection of platelet rich plasma (PRP)

  • Placebo

    Other intervention

    Intra-articular Saline injection (0,6-1ml)

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Platelet rich plasma (PRP)Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain on load in thumb

Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)

Time frame
6 months after the first injection.

Secondary outcomes

1

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame
3 months
2

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame
6 months
3

Patient-rated Wrist and Hand (PRWHE) score

0-100, higher score represents more disability

Time frame
12 months
4

Nelson thumb score

0-100, lower score represents more symptoms

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov
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