Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite

NCT06382779 | Enrolling By Invitation DMC

• 1 other identifier: 2024PI057
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis.

Conditions

Shoulder Disease

Keywords

shoulder arthroplasty; reverse shoulder arthroplasty; allograft prosthetic composite

Outcome Measures

Primary Outcomes (1)

• Constant score

  Shoulder functional evaluation score : between 6 points ( worse outcome) and 100 points (better outcome)

  through clinical completion an average of 2 years

Secondary Outcomes (3)

• complication

  through clinical completion an average of 5 years

• mortality

  through clinical completion an average of 5 years

• revision

  through clinical completion an average of 5 years

Study Arms (2)

allograft prosthetic composite

patients treated with resection and reconstruction with reverse prostheses included in cryopreserved allografts

Procedure: reverse shoulder arthroplasty

cement sleeve

patients treated with resection and reconstruction with suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve

Procedure: reverse shoulder arthroplasty

Interventions

reverse shoulder arthroplasty PROCEDURE

resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty

allograft prosthetic composite; cement sleeve

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 of this tumors
• primary reconstruction

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU - Centre chirurgical emile galle

Nancy, 54000, France

Location

Study Officials

• Francois SIRVEAUX

  Central Hospital, Nancy, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• 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: April 15, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

FR (1)