An observational study in Shoulder Disease, sponsored by Central Hospital, Nancy, France. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Central Hospital, Nancy, France · Observational
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.
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.
Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors
Exclusion Criteria:
patients treated with resection and reconstruction with reverse prostheses included in cryopreserved allografts
Procedure: reverse shoulder arthroplasty
patients treated with resection and reconstruction with suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve
Procedure: reverse shoulder arthroplasty
resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty
Constant score
Shoulder functional evaluation score : between 6 points ( worse outcome) and 100 points (better outcome)
Time frame: through clinical completion an average of 2 years
complication
dislocation, infection,
Time frame: through clinical completion an average of 5 years
mortality
death: intervention-related or non-intervention-related, cause of death, delay of death
Time frame: through clinical completion an average of 5 years
revision
reoperation (with or without implant extraction), cause of revision, delay of revision
Time frame: through clinical completion an average of 5 years
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Central Hospital, Nancy, France