Clinical Trial: Mononuclear Cells, Platelets and Zoledronic Acid for Preventing Collapse of the Femoral Head in Osteonecrosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Local Administration of Enriched Mononuclear Cells, Platelets and Zoledronic Acid for Preventing Collapse of the Femoral Head in the Early Stage of Osteonecrosis: a Prospe

Brief Summary: This study was mainly aimed to evaluate the efficacy of local administration of enriched bone marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of collapse of the early-stage osteonecrotic femoral head.

Detailed Summary:

Osteonecrosis of the femoral head (ONFH) is a common degenerative disease caused by a variety of factors, such as trauma, alcoholism, use of corticosteroids, and systemic lupus erythematosus. In ONFH, the overall mechanical properties of the femoral head change over time, and collapse of the femoral head results in severe pain and disability.

Although there are numerous strategies for treating ONFH, conservative treatments are often ineffective. Once collapse of the femoral head occurs, hip replacement is the only option for ONFH patients. Therefore, it is important to reduce osteonecrotic weakening of the femoral head in the early stage of ONFH to prevent subsequent head collapse. Studies have shown that bisphosphonates inhibit osteoclast activity, reduce bone resorption, retain bone trabeculae, reduce apoptosis of osteoblasts and osteocytes, and promote new bone formation. Therefore, investigators have chosen to use bisphosphonates for preventing collapse of the osteonecrotic femoral head. Zoledronic acid is the most potent bisphosphonate for the treatment of ONFH. It can reduce bone resorption and preserve the shape of the femoral head. In most cases, bisphosphonates are given intravenously or orally. However, systemic administration is associated with many complications, including osteonecrosis of the mandible and atypical femur fractures. As previously reported, poly(lactic-co-glycolic acid) acts as a drug carrier to facilitate the local release of zoledronic acid, and it has been found to promote bone formation and help avoid the complications caused by systemic administration. Using this method of administration, zoledronic acid can reach locally therapeutic levels, thereby preventing femoral head collapse.

ONFH reduces the viability of bone marrow hematopoietic cells and bone cells to varying degrees, and can even
Sponsor: Chinese PLA General Hospital

Current Primary Outcome: Change of Magnetic resonance imaging(MRI) [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]

Dynamic perfusion MRI to observe the blood supply in the necrotic area


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of Three-dimensional CT [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
    Three-dimensional CT reconstruction of the hip joint to observe new bone formation in the necrotic area
  • Change of X-ray film [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
    Anteroposterior and lateral X-ray films to observe the outline of the femoral head
  • Change of Harris score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
    Harris score of the hip joint to assess hip joint function
  • Change of Numerical rating scale(NRS) score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
  • Change of SF-36 score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
  • Change of Activities of Daily Living (ADL) score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: March 17, 2016
Date Started: February 2012
Date Completion: May 2016
Last Updated: March 28, 2016
Last Verified: March 2016