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The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression (NEC15)

Primary Purpose

Hip Necrosis, Hip Injuries

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Core decompression procedure
Sponsored by
Dante Dallari, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Necrosis focused on measuring hip avascular necrosis, hip conservative surgery

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico Rizzli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hip avascular necrosis

Arm Description

patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria

Outcomes

Primary Outcome Measures

Avoiding arthroplasty
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)

Secondary Outcome Measures

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.
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
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.
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.

Full Information

First Posted
December 21, 2019
Last Updated
December 21, 2019
Sponsor
Dante Dallari, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04210440
Brief Title
The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2003 (Actual)
Primary Completion Date
March 1, 2011 (Actual)
Study Completion Date
March 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dante Dallari, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Necrosis, Hip Injuries
Keywords
hip avascular necrosis, hip conservative surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip avascular necrosis
Arm Type
Experimental
Arm Description
patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria
Intervention Type
Procedure
Intervention Name(s)
Core decompression procedure
Intervention Description
Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow
Primary Outcome Measure Information:
Title
Avoiding arthroplasty
Description
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)
Time Frame
24 months after surgery
Secondary Outcome Measure Information:
Title
Harris Hip Score
Description
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.
Time Frame
6 weeks after surgery
Title
Harris Hip Score
Description
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
Time Frame
3 months after surgery
Title
Harris Hip Score
Description
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.
Time Frame
6 months after surgery
Title
Harris Hip Score
Description
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.
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istituto Ortopedico Rizzli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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