Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors

Shoulder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06382792
• Other study ID #: 2024PI059
• Status: Enrolling by invitation
• Start date: May 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Disease

Intervention

Procedure:
• proximal humeral resection for tumor and allograft prosthetic composite reconstruction
allograft prosthetic composite

Locations

Country	Name	City	State
France	Central Hopital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteolysis (bone stock in cm3)	allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up	within 3 months post operatively and up to 1 year post operatively
Secondary	Constant score	Shoulder functional evaluation score between 6 points (worst score) and 100 points (better score)	up to 1year post operatively
Secondary	Complications	(infection, dislocation)	up to 1year post operatively
Secondary	Revision	with removal of implant, with or without re implantation	up to 1year post operatively