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

NCT02721940 | Unknown DMC

• 1 other identifier: PLAGH_001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteonecrosis

Outcome Measures

Primary Outcomes (1)

• Change of Magnetic resonance imaging(MRI)

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

  Before treatment and month 3, month 6, month 12,month 18 after surgery

Secondary Outcomes (6)

• Change of Three-dimensional CT

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of X-ray film

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of Harris score

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of Numerical rating scale(NRS) score

  Before treatment and month 3, month 6, month 12,month 18 after surgery

• Change of SF-36 score

  Before treatment and month 3, month 6, month 12,month 18 after surgery

Study Arms (2)

Treatment group

EXPERIMENTAL

In the treatment group, patients will be given local injection of enriched autologous mononuclear cells and zoledronic acid into the necrotic area following core decompression by drilling.

Biological: Mononuclear Cells; Biological: Platelets; Drug: Zoledronic Acid; Drug: Normal saline

Control group

EXPERIMENTAL

In the control group, core decompression will be performed, but no treatment will be given.

Procedure: Control group

Interventions

Control group PROCEDURE

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

Also known as: Arthroscopic debridement and microfracture surgery

Control group

Mononuclear Cells BIOLOGICAL

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.

Treatment group

Platelets BIOLOGICAL

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.

Treatment group

Zoledronic Acid DRUG

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.

Treatment group

Normal saline DRUG

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.

Treatment group

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• Either sex
• Patients with Ficat I-II ONFH confirmed by anteroposterior and lateral X-ray and CT films
• No collapse of the femoral head
• No previous ONFH-related surgery
• Tolerant to anesthesia and surgical procedures

You may not qualify if:

• Inability to tolerate surgical procedures
• Blood diseases
• Bleeding tendency
• Drug addictions (narcotics, anesthetics and/or alcohol)
• Inflammatory arthritis (specific or non-specific arthritis)
• Immune system disorders
• Metabolic disease (gout, rheumatism)
• Lactating or pregnant women, or women who are preparing to conceive within
• year after initial recruitment
• Patients with psychiatric disorders who have poor compliance and cannot complete the rehabilitation therapy

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Osteonecrosis

Interventions

Control Groups; Platelet Count; Zoledronic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Quanyi Guo, Ph.D

  Institute of Orthopedics, Chinese PLA Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 29, 2016
• Study Start: February 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03