Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors

NCT06382792 | Enrolling By Invitation DMC

• 1 other identifier: 2024PI059
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Constant score

  up to 1year post operatively

• Complications

  up to 1year post operatively

• Revision

  up to 1year post operatively

Interventions

proximal humeral resection for tumor and allograft prosthetic composite reconstruction PROCEDURE

allograft prosthetic composite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Central Hopital

Nancy, 54000, France

Location

MeSH Terms

Interventions

Tumor Burden

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Anthropometry; Investigative Techniques

Study Officials

• Sirveaux FRANCOIS

  Central Hopital, Nancy France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)