Transcription Factor Runx2 in Necrotic Femoral Head Tissue

NCT02735538 | Completed

• 1 other identifier: ShengjingH_LQYang
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The trial detected mRNA expression of several bone repair-related genes, including Runx2, in the femoral head and neck of patients with osteonecrosis of femoral head (ONFH) . Runx2 expression was compared with that of identical tissue from osteoarthritis patients to identify expression in necrotic femoral head tissue, which will help clarify the role and possible clinical significance of Runx2 in femoral head necrosis, bone repair and reconstruction.

Conditions

Osteonecrosis of Femoral Head

Outcome Measures

Primary Outcomes (1)

• Runx2 mRNA expression in femoral head and neck tissue

  Runx2, a primary transcription factor controlling osteoblast commitment and differentiation, can be considered an osteoblast phenotype marker.

  During surgery

Secondary Outcomes (4)

• bone morphogenetic protein-2(BMP-2)

  During surgery

• bone morphogenetic protein-7(BMP-7)

  During surgery

• osteoprotegerin

  During surgery

• osteocalcin immunoreactivity

  During surgery

Study Arms (2)

osteonecrosis of femoral head group

The patients with osteonecrosis of femoral head undergo total hip replacement. Femoral head specimens will be collected and ex vivo specimens numbered. Using RT-PCR, Runx2, BMP-2, BMP-7 and osteoprotegerin, mRNA expression levels will be quantitatively analyzed. Osteocalcin immunoreactivity will be detected using immunohistochemical staining.

Procedure: osteonecrosis of femoral head group

osteoarthritis group

The patients with osteoarthritis will undergo total hip replacement. Femoral head specimens will be collected and ex vivo specimens numbered. Using RT-PCR, Runx2, BMP-2, BMP-7 and osteoprotegerin, mRNA expression levels will be quantitatively analyzed. Osteocalcin immunoreactivity will be detected using immunohistochemical staining.

Procedure: osteoarthritis group

Interventions

osteonecrosis of femoral head group PROCEDURE

The patients with osteonecrosis of femoral head will undergo total hip replacement.

osteonecrosis of femoral head group

osteoarthritis group PROCEDURE

The patients with osteoarthritis will undergo total hip replacement.

osteoarthritis group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifteen patients with ONFH at Ficat Stage III¬-IV and 15 patients with osteoarthritis will undergo total hip replacement. Femoral head specimens will be collected and ex vivo specimens numbered. Using RT-PCR, Runx2, BMP-2, BMP-7 and osteoprotegerin, mRNA expression levels will be quantitatively analyzed. Osteocalcin immunoreactivity will be detected using immunohistochemical staining. Professional staff, blinded to grouping, will perform outcome index detection and statistical analysis.

You may qualify if:

• Diagnosed as ONFH at Ficat Stage III-IV by anteroposterior and lateral X- ray and/or computed tomography (CT) images
• Diagnosed with hip joint osteoarthritis by laboratory examinations and X-ray images
• Subjected to total hip replacement for the first time
• Able to tolerate anesthesia and surgery
• Provide informed consent regarding the benefits and risks of participation in the trial

You may not qualify if:

• Complicated by severe primary cardiovascular disease, hepatic and/or renal inadequacy, or hematopoietic system disorders
• Pregnant or lactating woman
• With blood coagulation disorder
• With a history of epilepsy or mental disorder
• Have participated in other clinical trials within 30 days prior to recruitment
• Are taking part in other clinical trials
• Cannot manage him/herself or have poor self-control ability
• Human immunodeficiency virus (HIV)-positive or hepatitis virus-positive
• Active systemic or local infection
• Poor tolerance to total hip replacement

Sponsors & Collaborators

• Shengjing Hospital: lead

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Liqing Yang, M.D.

  Shengjing Hospital of China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 13, 2016

Record last verified: 2016-04