The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression

Hip Injuries Clinical Trial

— NEC15  

Official title:

Core Decompression With Bone Chips Allograft Adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS): Results in Avascular Necrosis of Femoral Head (AVN) After 2 Years Minimum Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210440
• Other study ID #: 0029170
• Status: Completed
• Phase: N/A
• Start date: March 1, 2003
• Est. completion date: March 1, 2012

Study information

• Verified date: December 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).

Description:

We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).

The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year.

The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR), while the secondary outcomes were the assessment of any change in clinical performance as measured by Harris Hip Score

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2012
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• hip avascular necrosis

Exclusion Criteria:

• protrusio acetabuli

• concentric femoral head migration;

• presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)

• presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);

• concomitant rheumatic diseases;

• bone tumors

Related Conditions & MeSH terms

• Hip Injuries
• Hip Necrosis
• Necrosis

Intervention

Procedure:
• Core decompression procedure
Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Dante Dallari, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avoiding arthroplasty	The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)	24 months after surgery
Secondary	Harris Hip Score	The collection of functional outcomes score HHS at 6 weeks. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.	6 weeks after surgery
Secondary	Harris Hip Score	The collection of functional outcomes score HHS at 3 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results	3 months after surgery
Secondary	Harris Hip Score	The collection of functional outcomes score HHS at 6 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.	6 months after surgery
Secondary	Harris Hip Score	The collection of functional outcomes score HHS at 12 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.	12 months after surgery