Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors

• Conditions: Shoulder Disease

• Registration Number: NCT06382792
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Study Start: 2024-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteolysis (bone stock in cm3)	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 Outcome Measures

Name	Time	Method
Constant score	up to 1year post operatively	Shoulder functional evaluation score between 6 points (worst score) and 100 points (better score)
Complications	up to 1year post operatively	(infection, dislocation)
Revision	up to 1year post operatively	with removal of implant, with or without re implantation

Trial Locations

Locations (1)

Central Hopital; 🇫🇷 Nancy, France