Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

NCT02941666 | Terminated DMC

• 1 other identifier: 16-002241
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown an increase in the concentration of mesenchymal stem cells (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head.

Conditions

Osteonecrosis

Outcome Measures

Primary Outcomes (1)

• The quantity of mesenchymal stem cells present in the synovial fluid of patients with precollapse ON of the femoral head and postcollapse ON of the femoral head compared to patients without intraarticular hip pathology.

  Previous studies have shown an increase in the concentration of MSCs in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head. Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage.

  24 months

Study Arms (3)

Collapse ON group

This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with post collapse osteonecrosis.

Pre-collapse group

This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with pre-collapse osteonecrosis.

FAI group

This control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified in clinic as scheduled for total hip arthroplasty, hip arthroscopy or minimally invasive core decompression of the femoral head after granting consent.

You may qualify if:

• Patients consented to undergo a THA (post-collapse osteonecrosis), hip arthroscopy or minimally invasive core decompression
• Preoperative radiographic diagnosis of ON or FAI (femoral/acetabular impingement)

You may not qualify if:

• Pregnant females
• Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
• Patients receiving hematopoetic growth factors or anti-angiogenesis products

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Raphael J. Sierra, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

US (1)