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

NCT03129971 | Unknown DMC

• 1 other identifier: QinghaiUH_008
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nonunion of Fracture

Outcome Measures

Primary Outcomes (1)

• Fracture healing rate

  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.

  month 9 after surgery

Secondary Outcomes (1)

• Visual analogue scale scores

  changes of baseline and month 3, month 6, month 9, month 12 after surgery

Study Arms (2)

control group

EXPERIMENTAL

Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to control group, which received conventional surgery.

Procedure: conventional surgery

experimental group

EXPERIMENTAL

Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to experimental group, which are injected with autologous platelet-rich plasma on the basis of conventional surgery.

Procedure: autologous platelet-rich plasma

Interventions

conventional surgery PROCEDURE

Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to control group, which received conventional surgery.

Also known as: control group

control group

autologous platelet-rich plasma PROCEDURE

Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to experimental group, which are injected with autologous platelet-rich plasma on the basis of conventional surgery.

Also known as: experimental group

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Femoral shaft fractures
• Fracture time is more than 9 months
• X-ray reveals gap and sclerosis at the fracture ends, medullary closure, osteoporosis, with the absence of trabecular bone formation among callus, and for more than 3 months
• Magnetic resonance imaging reveals widened gap and atrophic fracture ends, a small amount or even no callus formation
• Histological examination reveals that the gap at the fracture ends is filled with fibrous tissue without osteogenic activity
• Age of 18-70 years

You may not qualify if:

• The underlying disease that affects wound healing, such as diabetes, hematological system diseases, immune diseases, connective tissue diseases
• Pregnancy or lactation
• Heart, lung, liver, and kidney dysfunction
• Participate in other clinical trials

Sponsors & Collaborators

• Qinghai University: lead

MeSH Terms

Conditions

Fractures, Ununited

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zichun Zhao, bachelor

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with atrophic nonunion of femoral shaft fractures, who were treated at the Affiliated Hospital of Qinghai University, China.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 26, 2017
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04