An interventional study of Core decompression procedure in Hip Necrosis and Hip Injuries, sponsored by Dante Dallari, MD. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by Dante Dallari, MD · Not applicable, Interventional, and Treatment
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
478 studies on the registry are indexed under Necrosis; 55 are open to participants now.
This study's enrollment of 52 is close to the median of 56 across 316 interventional studies indexed under Necrosis.
Browse Necrosis studies →This is the only study on the registry with Dante Dallari, MD as lead sponsor.
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Exclusion Criteria:
patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria
Procedure: 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
Avoiding arthroplasty
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)
Time frame: 24 months after surgery
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
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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