Clinical trial NCT06382779: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
Official title: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Shoulder Disease
Keywords: shoulder arthroplasty
reverse shoulder arthroplasty
allograft prosthetic composite
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Constant score
timeFrame: through clinical completion an average of 2 years
Secondary outcomes:
measure: complication
timeFrame: through clinical completion an average of 5 years
measure: mortality
timeFrame: through clinical completion an average of 5 years
measure: revision
timeFrame: through clinical completion an average of 5 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU - Centre chirurgical emile galle
Study officials:
affiliation: Central Hospital, Nancy, France
name: Francois SIRVEAUX
role: STUDY_CHAIR
References: