Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-26 @ 2:39 AM
Study NCT ID:
NCT06382792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).
The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).
The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).
Detailed Description:
quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.
This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.
This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: