Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

NCT03787329 | Unknown DMC

• 1 other identifier: RD-106057
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.

Conditions

Avascular Necrosis of Femur; Bone Marrow

Keywords

Femur Head Necrosis; Mesenchymal Stromal Cells; Bone Marrow

Outcome Measures

Primary Outcomes (1)

• 3-month postoperative hip function evaluated by Harris Hip Score

  Hip function is evaluated using Harris Hip score. The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

  3-month postoperative

Secondary Outcomes (6)

• 6-month postoperative hip function evaluated by Harris Hip Score

  6-month postoperative

• 12-month postoperative hip function evaluated by Harris Hip Score

  12-month postoperative

• 3-month postoperative degree of collapse evaluated by plain radiograph

  3-month postoperative

• 6-month postoperative degree of collapse evaluated by plain radiograph

  6-month postoperative

• 12-month postoperative degree of collapse evaluated by plain radiograph

  12-month postoperative

Study Arms (2)

Bone marrow concentration group

The patients receive core decompression surgery with bone marrow concentration.

Other: Core decompression surgery with bone marrow concentration

Historical control group

The previous age-, gender-, and stage-matched patients who received core decompression surgery only.

Other: Core decompression surgery

Interventions

Core decompression surgery with bone marrow concentration OTHER

Core decompression surgery with bone marrow concentration

Bone marrow concentration group

Core decompression surgery OTHER

Core decompression surgery only

Historical control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

consecutive eligible patients who underwent core decompression combined with autologous bone marrow stem cells treatment for avascular necrosis of the femoral head

You may qualify if:

• Age between 30 and 60 years
• With diagnosis of avascular necrosis of femoral head, Stage I - Stage III

You may not qualify if:

• With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
• With prior history of hip surgery
• With current or prior history of trauma or infection at hip
• Platelet count \< 50,000/µL
• With current diagnosis of coagulopathy
• With current or prior history of cancer
• With current or prior history of hematological disease
• Pregnancy
• Patients who will not cooperate with one-year followup

Sponsors & Collaborators

• Pei-Yuan Lee, MD: lead
• Aeon Biotechnology Corporation: collaborator

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Yuan Lee, MD

  Show Chwan Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Chang-Han Chuang, MD

CONTACT

+886-975611794; skyman889@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Superintendent

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: December 26, 2018
• Study Start: April 14, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)