The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression
NCT ID: NCT04210440
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2003-03-01
2012-03-01
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hip avascular necrosis
patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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Dante Dallari, MD
OTHER
Responsible Party
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Dante Dallari, MD
MD
Locations
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Istituto Ortopedico Rizzli
Bologna, , Italy
Countries
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Other Identifiers
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0029170
Identifier Type: -
Identifier Source: org_study_id