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Clinical Trials/NCT06382792
NCT06382792
Enrolling By Invitation
Not Applicable

Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors

Central Hospital, Nancy, France1 site in 1 country6 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Disease
Sponsor
Central Hospital, Nancy, France
Enrollment
6
Locations
1
Primary Endpoint
Osteolysis (bone stock in cm3)
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
May 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

PEDUZZI Lisa

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • tumors of proximal humerus
  • Malawer type I resection
  • primary reconstruction by allograft prosthetic composite

Exclusion Criteria

  • resection and reconstruction by prosthesis alone
  • resection and reconstruction by prosthesis and cement sleeve reconstruction
  • resection and reconstruction by hemiarthroplasty
  • revision protheses.

Outcomes

Primary Outcomes

Osteolysis (bone stock in cm3)

Time Frame: within 3 months post operatively and up to 1 year post operatively

allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up

Secondary Outcomes

  • Constant score(up to 1year post operatively)
  • Complications(up to 1year post operatively)
  • Revision(up to 1year post operatively)

Study Sites (1)

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