Clinical Trial: Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.

Detailed Summary:

Severe haemophilia 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, which are associated with limitation of range of motion (ROM), pain, muscle atrophy, functional impairment, and poor quality of life. The knee, elbow, and ankle are the most commonly involved joints and arthropathy could worsen in adolescence or young adulthood. Hemophilic arthropathy is a multifactorial event and there is evidence to suggest that iron may play a major role with release of cytokines such as Interleukin ( IL)-1, IL-6, and tumour necrosis factor alpha (TNF-α) leading to chronic proliferative synovitis, hypervascularity, and progressive arthropathy. These effects on cartilage and subchondral bone are inflammatory and degenerative in nature and management of chronic hemophilic arthropathy is difficult.

Currently available drugs for the treatment of hemophilic arthropathy, such as analgesics, corticosteroids, nonsteroid and steroid anti-inflammatory drugs, 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. Growth factors including platelet derived growth factor (PDGF), insulin growth factor (IGF), vascular endothelial growth factor, and transforming growth factor beta-1 are believed to be key components of PRP for structural repair. Although comparing PRP with other intra-articular and so
Sponsor: Tri-Service General Hospital

Current Primary Outcome: Pain (visual analogue scale) and Change from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  It consists of 24 items: five pertaining to pain perception, two to stiffness, and 17 to physical function.
• Short Form-36 (SF-36) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  The SF-36 is a 36-item assessment tool that measures eight general health concepts including physical functioning, role limitation due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
• Ultrasonographic synovial thickness (mm) and Change from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  Synovial thickness (mm) by ultrasonography were evaluated from the lateral, middle, and medial aspects of the anterior suprapatellar recess
• Synovial hyperemia (score) and Change from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  Power Doppler assessment of the selected synovial sites was performed with settings standardized to a pulse repetition frequency of 700 Hz. The power Doppler gain was adjusted to a level just below the disappearance of artifacts under the bony cortex.14,15 The intensity of blood flow in the synovium was scored on a semiquantitative scale from 0-3 (grade 0, no intraarticular colour signal; grade 1, up to 3 color signals or 2 single and 1 confluent signal in the intraarticular area; grade 2, greater than grade 1 to <50% of the intraarticular area filled with color signals; grade 3, ≥50% of the intraarticular area filled with color signals)
• Range of Motion (ROM, degrees) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
• Hemarthrosis (times) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]

Original Secondary Outcome:

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  It consists of 24 items: five pertaining to pain perception, two to stiffness, and 17 to physical function.
• Short Form-36 (SF-36) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  The SF-36 is a 36-item assessment tool that measures eight general health concepts including physical functioning, role limitation due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
• Ultrasonographic synovial thickness (mm) and Change from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  Synovial thickness (mm) by ultrasonography were evaluated from the lateral, middle, and medial aspects of the anterior suprapatellar recess
• Synovial hyperemia (score) and Change from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
  Power Doppler assessment of selected synovial sites is carried out with settings standardized to a pulse repetition frequency of 700 Hz. The intensity of the blood flow in the synovium is scored into 0 to 3 (0=No flag; 1 = 1 flag; 2 = 2-3 flags; 3=>3 flags) adapted from Klukowska and Melchiorre et al
• Range of Motion (ROM, degrees) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]
• Hemarthrosis (times) from Baseline at 1, 2, 3 &6 months [ Time Frame: baseline, 1 month, 2 months, 3 months, 6 months ]

Dates:
Date Received: November 7, 2015
Date Started: June 2014
Date Completion:
Last Updated: April 30, 2016
Last Verified: April 2016