Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382779
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Brief Title:
Proximal Humerus Reconstruction After Resection for Tumors Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Proximal Humerus Reconstruction After Resection for Tumors Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
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:
Proximal humerus is a common site for primary bone tumors and metastatic disease Reconstruction with reverse shoulder arthroplasty RSA after resection is a surgical challenge and presented high risk of complication The options for reconstruction after proximal humerus tumor resection are limited and depend on the soft tissue conditions and bone loss The most commonly used techniques include long cemented stem alone in case of limited resection allograft prosthetic composite APC massive prosthesis In some cases two step procedure are performed first step is resection and RSA with cement sleeve and second step is APC or massive prosthesis
Detailed Description:
Theses surgical options are complex technically challenging and at risk of complications dislocation infections allograft pseudarthrosis High complication rate length of the surgical procedure and post-operative recovery are a concern for theses frail patients
Timing before being able to schedule the intervention selection of the appropriately sized allograft restricted access to grafts is also an issue Postponing cancer resection surgery increases the risk of both local and distant tumor invasion In case of secondary bone tumors surgery is often decided for pain relief rather than with a curative intent In cases where rapid bone graft is not available and urgent surgery is required for pain or for oncological reasons the bone loss can be compensated for by a temporary cement sleeve In some cases either because life expectancy has improved or has been longer than anticipated or because the patient declined a second surgery for the implantation of an allograft some patients can stay with the reconstruction with a long-cemented stem and cement sleeve
The objective of this study was to compare functional outcomes and complications between APC and cement sleeve reconstruction Our hypothesis was that in cases of proximal humerus resection for tumors reverse prostheses included in cryopreserved allografts would yield better clinical results and greater longevity than suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve
Timing before being able to schedule the intervention selection of the appropriately sized allograft restricted access to grafts is also an issue Postponing cancer resection surgery increases the risk of both local and distant tumor invasion In case of secondary bone tumors surgery is often decided for pain relief rather than with a curative intent In cases where rapid bone graft is not available and urgent surgery is required for pain or for oncological reasons the bone loss can be compensated for by a temporary cement sleeve In some cases either because life expectancy has improved or has been longer than anticipated or because the patient declined a second surgery for the implantation of an allograft some patients can stay with the reconstruction with a long-cemented stem and cement sleeve
The objective of this study was to compare functional outcomes and complications between APC and cement sleeve reconstruction Our hypothesis was that in cases of proximal humerus resection for tumors reverse prostheses included in cryopreserved allografts would yield better clinical results and greater longevity than suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None