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

NCT02601170 | Completed Results

• 1 other identifier: 2-102-05-019
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemophilia; Hemophilic Arthropathy

Keywords

Platelet Rich Plasma; Hemophilia; Hemophilic arthropathy

Outcome Measures

Primary Outcomes (1)

• Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months

  The pain intensity will be evaluated subjectively on a visual analogue scale (0-10). Higher scores mean a worse outcome.

  baseline, 1 month, 2 months, 3 months, 6 months

Secondary Outcomes (6)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months

  baseline, 1 month, 2 months, 3 months, 6 months

• Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months

  baseline, 1 month, 2 months, 3 months, 6 months

• Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months

  baseline, 1 month, 2 months, 3 months, 6 months

• Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months

  baseline, 1 month, 2 months, 3 months, 6 months

• Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months

  baseline, 1 month, 2 months, 3 months, 6 months

Study Arms (2)

PRP Group

EXPERIMENTAL

single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)

Biological: Platelet-Rich Plasma Intra-Articular Injection

HA Group

ACTIVE COMPARATOR

five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).

Drug: Hyaluronic Acid Viscosupplementation

Interventions

Platelet-Rich Plasma Intra-Articular Injection BIOLOGICAL

PRP Group

Hyaluronic Acid Viscosupplementation DRUG

HA Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Tsung-Ying Li
• Organization: Tri-service general hospital

doc31141@gmail.com

886-2-87927166

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 10, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 17, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-08