Shoulder DiseaseNCT06382779
Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
An observational study of Shoulder Disease, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Disease
- What is being tested?
- reverse shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors
Who may be able to join
- tumors of proximal humerus
- Malawer type I resection of this tumors
- primary reconstruction
Who cannot join
- resection and reconstruction by prosthesis alone
- resection and hemiarthroplasty reconstruction
- resection and revision protheses.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Shoulder Disease
- Being tested
- reverse shoulder arthroplasty
- Keywords
- shoulder arthroplasty, reverse shoulder arthroplasty, allograft prosthetic composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse shoulder arthroplastyProcedure or surgery
resection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| allograft prosthetic composite | patients treated with resection and reconstruction with reverse prostheses included in cryopreserved allografts Receives: Procedure: reverse shoulder arthroplasty | |
| cement sleeve | patients treated with resection and reconstruction with suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve Receives: Procedure: reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
Shoulder functional evaluation score : between 6 points ( worse outcome) and 100 points (better outcome)
Measured: through clinical completion an average of 2 years
Secondary outcomes (3)
complication
dislocation, infection,
Measured: through clinical completion an average of 5 years
mortality
death: intervention-related or non-intervention-related, cause of death, delay of death
Measured: through clinical completion an average of 5 years
revision
reoperation (with or without implant extraction), cause of revision, delay of revision
Measured: through clinical completion an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PEDUZZI Lisa, Central Hospital, Nancy, France
- Investigators
- Francois SIRVEAUX, Study chair, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382779
- Sponsor's protocol ID
- 2024PI057
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite
- ClinicalTrials.gov ID
- NCT06382779
- Acronym / sponsor ID
- 2024PI057
- Conditions
- Shoulder Disease
- Keywords
- shoulder arthroplasty, reverse shoulder arthroplasty, allograft prosthetic composite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allograft prosthetic composite | – | Procedure: reverse shoulder arthroplastypatients treated with resection and reconstruction with reverse prostheses included in cryopreserved allografts |
| cement sleeve | – | Procedure: reverse shoulder arthroplastypatients treated with resection and reconstruction with suspended prostheses with proximal metaphyseal reconstruction using a cement sleeve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors
Key inclusion criteria (3 listed)
- tumors of proximal humerus
- Malawer type I resection of this tumors
- primary reconstruction
Key exclusion criteria (3 listed)
- resection and reconstruction by prosthesis alone
- resection and hemiarthroplasty reconstruction
- resection and revision protheses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reverse shoulder arthroplastyresection of proximal humeral tumors and reconstruction with reverse shoulder arthroplasty | Procedure or surgery | allograft prosthetic composite, cement sleeve |
Primary outcome
Constant score
Time frame: through clinical completion an average of 2 years
Shoulder functional evaluation score : between 6 points ( worse outcome) and 100 points (better outcome)
3 secondary outcomes
complication
Time frame: through clinical completion an average of 5 years
mortality
Time frame: through clinical completion an average of 5 years
revision
Time frame: through clinical completion an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois SIRVEAUX study chair
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score (time frame: through clinical completion an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.