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

NCT02721940 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-29

No results posted yet for this study

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.

Conditions

  • Osteonecrosis

Interventions

PROCEDURE

Control group

Patients in the control group will be subjected to arthroscopic debridement and microfracture surgery.

BIOLOGICAL

Mononuclear Cells

In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.

BIOLOGICAL

Platelets

In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.

DRUG

Zoledronic Acid

In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.

DRUG

Normal saline

In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Quanyi Guo, Ph.D · Institute of Orthopedics, Chinese PLA Hospital, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-01-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02721940 on ClinicalTrials.gov