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

Shoulder Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06382779
• Other study ID #: 2024PI057
• Status: Enrolling by invitation
• Start date: April 15, 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

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.

Description:

Theses surgical options are complex, technically challenging, and at risk of complications (dislocation, infections, allograft pseudarthrosis…). High complication rate, length of the surgical procedure and post-operative recovery are a concern for theses frail patients.

Timing before being able to schedule the intervention (selection of the appropriately sized allograft, restricted access to grafts…) is also an issue. Postponing cancer resection surgery increases the risk of both local and distant tumor invasion. In case of secondary bone tumors, surgery is often decided for pain relief rather than with a curative intent. In cases where rapid bone graft is not available, and urgent surgery is required for pain or for oncological reasons, the bone loss can be compensated for by a temporary cement sleeve . In some cases, either because life expectancy has improved or has been longer than anticipated, or because the patient declined a second surgery for the implantation of an allograft, some patients can stay with the reconstruction with a long-cemented stem and cement sleeve.

The objective of this study was to compare functional outcomes and complications between APC and cement sleeve reconstruction. Our hypothesis was that, in cases of proximal humerus resection for tumors, reverse prostheses included in cryopreserved allografts would yield better clinical results and greater longevity than suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• 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 of this tumors

• primary reconstruction

Exclusion Criteria:

• resection and reconstruction by prosthesis alone

• resection and hemiarthroplasty reconstruction

• resection and revision protheses.

Related Conditions & MeSH terms

• Shoulder Disease

Intervention

Procedure:
• reverse shoulder arthroplasty
resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty

Locations

Country	Name	City	State
France	CHRU - Centre chirurgical emile galle	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	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	complication	dislocation, infection,	through clinical completion an average of 5 years
Secondary	mortality	death: intervention-related or non-intervention-related, cause of death, delay of death	through clinical completion an average of 5 years
Secondary	revision	reoperation (with or without implant extraction), cause of revision, delay of revision	through clinical completion an average of 5 years