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Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06382792
Enrollment
6
Registered
2024-04-24
Start date
2024-05-01
Completion date
2024-05-01
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Disease

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.

Interventions

PROCEDUREproximal humeral resection for tumor and allograft prosthetic composite reconstruction

allograft prosthetic composite

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Osteolysis (bone stock in cm3)within 3 months post operatively and up to 1 year post operativelyallograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up

Secondary

MeasureTime frameDescription
Constant scoreup to 1year post operativelyShoulder functional evaluation score between 6 points (worst score) and 100 points (better score)
Complicationsup to 1year post operatively(infection, dislocation)
Revisionup to 1year post operativelywith removal of implant, with or without re implantation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026