N/A N=22 Single-blind Treatment

Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy

Hemophilia · Hemophilic Arthropathy

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View on ClinicalTrials.gov: NCT02601170 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months — 5.0; 4.1; 2.5; 1.8 scores on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Platelet-Rich Plasma Intra-Articular Injection (Biological); Hyaluronic Acid Viscosupplementation (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tri-Service General Hospital
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months	5.0; 4.1; 2.5; 1.8; 2.4; 1.6	<0.05 sig
SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months	38.3; 33.4; 28.7; 19.1; 27.3; 21.3	—
SECONDARY Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months	56.7; 54.7; 62.8; 58.5; 63.5; 63.5	—
SECONDARY Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months	8.0; 6.9; 7.1; 6.5; 7.0; 6.1	—
SECONDARY Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months	1.0; 0.9; 0.9; 0.4; 0.3; 0.2	—
SECONDARY Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months	92.3; 90.9; 99.5; 91.8; 102.3; 91.8	—
SECONDARY Hemarthrosis From Baseline at 1, 2, 3 &6 Months	0.5; 0.7; 0.4; 0.4; 0; 0.3	—

Summary

Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage damage and bony destruction. Currently available treatment of hemophilic arthropathy, such as analgesics, NSAIDs, and hyaluronic acid (HA), are predominantly directed toward the symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage degeneration. Platelet-Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural concentrate of autologous growth factors from the blood. This method is now being increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon repairment and osteoarthritis. To the best of our knowledge, no study applies PRP for arthropathy of knee joint in hemophilia patients. The aim of the study is to investigate the efficacy, safety and duration of benefit of single PRP injection versus five weekly intra-articular injections of HA in patients with hemophilic arthropathy of knee.

Eligibility Criteria

Inclusion Criteria

hemophilia patients with hemophilic arthropathy of knee joints for at least 6 months
painful (VAS ≥ 3) hemophilic arthropathy of knee joints after medication

Exclusion Criteria

presence of joint infections, any surgery on the joint in preceding 12 months
intra-articular corticosteroid or HA injection within the past 6 months
treatment with systemic steroids
history of rheumatoid arthritis, or gouty arthropathy
history of chicken or egg allergy
presence of neoplasm
use of non steroidal anti-inflammatory drugs in the 5 days before study
platelet values < 100,000/mm3
acute hemarthrosis
paresis, or recent trauma.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02601170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.