Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors

April 22, 2024 updated by: PEDUZZI Lisa, Central Hospital, Nancy, France

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Central Hopital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 3 months post operatively and up to 1 year post operatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Chair: Sirveaux FRANCOIS, Central Hopital, Nancy France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024PI059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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