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

Central Hospital, Nancy, France

Status: Invitation-only

Conditions: Shoulder Disease

Treatments: Procedure: reverse shoulder arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT06382779

2024PI057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

allograft prosthetic composite

Description:

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

Treatment:

Procedure: reverse shoulder arthroplasty

cement sleeve

Description:

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

Treatment:

Procedure: reverse shoulder arthroplasty