ClinicalTrials.Veeva

Menu

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

D

Dante Dallari, MD

Status

Completed

Conditions

Hip Injuries
Hip Necrosis

Treatments

Procedure: Core decompression procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT04210440
0029170

Details and patient eligibility

About

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).

Full 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

Enrollment

52 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

Hip avascular necrosis
Experimental group
Description:
patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria
Treatment:
Procedure: Core decompression procedure

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems