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

Not Applicable

Completed

• Conditions: Hip Necrosis; Hip Injuries
• Interventions: Procedure: Core decompression procedure

• Registration Number: NCT04210440
• Lead Sponsor: Dante Dallari, MD

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

Study Timeline

• Study Start: 2003-03-01
• Primary Completion: 2011-03-01
• Study Completion: 2012-03-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-21
• Study First Submitted QC: 2019-12-21
• Last Update Submitted: 2019-12-21
• Study First Posted: 2019-12-24
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hip avascular necrosis	Core decompression procedure	patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria

Primary Outcome Measures

Name	Time	Method
Avoiding arthroplasty	24 months after surgery	The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	12 months after surgery	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzli; 🇮🇹 Bologna, Italy