Clinical trial NCT06193499: A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Official title: A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Thumb
Keywords: CMC-1 joint
thumb basal joint
PRP
Platelet-rich plasma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain on load in thumb
timeFrame: 6 months after the first injection.
Secondary outcomes:
measure: Patient-rated Wrist and Hand (PRWHE) score
timeFrame: 3 months
measure: Patient-rated Wrist and Hand (PRWHE) score
timeFrame: 6 months
measure: Patient-rated Wrist and Hand (PRWHE) score
timeFrame: 12 months
measure: Nelson thumb score
timeFrame: 3 months
measure: Nelson thumb score
timeFrame: 6 months
measure: Nelson thumb score
timeFrame: 12 months
measure: HAKIR symptom score (HQ-8)
timeFrame: 3 months
measure: HAKIR symptom score (HQ-8)
timeFrame: 6 months
measure: HAKIR symptom score (HQ-8)
timeFrame: 12 months
measure: key pinch and pinch strength
timeFrame: 3 months
measure: key pinch and pinch strength
timeFrame: 6 months
measure: key pinch and pinch strength
timeFrame: 12 months
measure: Radial and palmar abduction
timeFrame: 3 months
measure: Radial and palmar abduction
timeFrame: 6 months
measure: Radial and palmar abduction
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Hand Surgery Södersjukhuset
Study officials:
References: