Proximal Humerus Reconstruction After Resection for Tumors : Comparison

Status Enrolling by invitation

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Shoulder Disease

Clinical Trial Details

NCT number	NCT06382779
Study type	Observational
Source	Central Hospital, Nancy, France
Contact
Status	Enrolling by invitation
Phase
Start date	April 15, 2024
Completion date	May 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms