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

Dante Dallari, MD52 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hip Necrosis Hip Injuries

Interventions

Core decompression procedurePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Rizzli

Bologna, Italy

Outcomes

Primary Outcomes

Avoiding arthroplasty

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

Time frame: 24 months after surgery

Secondary Outcomes

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.

Time frame: 6 weeks after surgery

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

Time frame: 3 months after surgery

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.

Time frame: 6 months after surgery

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.

Time frame: 12 months after surgery

Data from ClinicalTrials.gov

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