Clinical Trial: Platelet-rich Plasma Combined With Conventional Surgery in the Treatment of Atrophic Nonunion of Femoral Shaft Fractures

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

Official Title: Platelet-rich Plasma Combined With Conventional Surgery in the Treatment of Atrophic Nonunion of Femoral Shaft Fractures: a Prospective, Randomized, Controlled Clinical Trial

Brief Summary: To objectively analyze the effectiveness of platelet-rich plasma (PRP) combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures.

Detailed Summary:

History and current related studies:

Fracture healing is a continuous process, and if any phase is disturbed by unfavorable factors, the healing process will be blocked. Clinical studies have found that non-healing rate of long bone fracture was approximately 5%. A certain site and type of fracture, if not healed within a mean time (usually 3-6 months), is called delayed union by US Food and Drug Administration. Simultaneously, the fracture that has not healed after 9 months and has no tendency for further healing in the next 3 months is called nonunion. According to fracture end activity, nonunion is classified into hypertrophic nonunion and atrophic nonunion.7, 8 Hypertrophic nonunion is mostly caused by unstable fixation of fracture ends, and can be cured by strengthening the stability of fracture site using conventional surgery. Atrophic nonunion is difficult to be cured, because of the lack of adequate blood supply and bone formation at the fracture ends, so it is unable to form the periosteal callus. At present, atrophic nonunion is commonly treated by internal and external fixation combined with autologous bone graft, but this method has a long treatment cycle, and there is a situation that cannot be cured.

Platelet-rich plasma (PRP) is blood plasma that has been enriched with platelets by centrifuging autologous blood. Platelet after activation can secrete platelet derived growth factor, transforming growth factor beta, vascular endothelial growth factor and epidermal growth factor. These growth factors can promote cell proliferation and differentiation, matrix synthesis and vascular regeneration, and accelerate tissue healing and bone repair. PRP contains a large number of leukocytes, which can locally phagocytize bacteria, scavenge necrotic tissue, inhibit inflammatory reaction, and resist infection. PRP fibrin c
Sponsor: Qinghai University

Current Primary Outcome: Fracture healing rate [ Time Frame: month 9 after surgery ]

To assess the condition of fracture healing. The disunion was identified if the fracture was not healed at postoperative 9 months. Fracture healing includes clinical healing and bone healing.


Original Primary Outcome: Same as current

Current Secondary Outcome: Visual analogue scale scores [ Time Frame: changes of baseline and month 3, month 6, month 9, month 12 after surgery ]

Visual analogue scale is a method to assess pain intensity. Using a ruler with 10 scales, the ends are 0 and 10, respectively. 0 represents no pain; 10 represents the most unbearable severe pain.


Original Secondary Outcome: Same as current

Information By: Qinghai University

Dates:
Date Received: April 18, 2017
Date Started: August 2014
Date Completion: December 2018
Last Updated: April 25, 2017
Last Verified: April 2017