Shoulder DiseaseNCT06382792
Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors
An observational study of Shoulder Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...). 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?
- proximal humeral resection for tumor and allograft prosthetic composite reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 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
- primary reconstruction by allograft prosthetic composite
Who cannot join
- resection and reconstruction by prosthesis alone
- resection and reconstruction by prosthesis and cement sleeve reconstruction
- resection and reconstruction by hemiarthroplasty
- revision protheses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors
The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).
The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).
Read the detailed description
quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.
This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.
- Conditions
- Shoulder Disease
- Being tested
- proximal humeral resection for tumor and allograft prosthetic composite reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal humeral resection for tumor and allograft prosthetic composite reconstructionProcedure or surgery
allograft prosthetic composite
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteolysis (bone stock in cm3)
allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up
Measured: within 3 months post operatively and up to 1 year post operatively
Secondary outcomes (3)
Constant score
Shoulder functional evaluation score between 6 points (worst score) and 100 points (better score)
Measured: up to 1year post operatively
Complications
(infection, dislocation)
Measured: up to 1year post operatively
Revision
with removal of implant, with or without re implantation
Measured: up to 1year post operatively
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 start1 May 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6 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
- Sirveaux FRANCOIS, Study chair, Central Hopital, Nancy France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382792
- Sponsor's protocol ID
- 2024PI059
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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
- Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors
- ClinicalTrials.gov ID
- NCT06382792
- Acronym / sponsor ID
- 2024PI059
- Conditions
- Shoulder Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 May 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.
The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).
The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).
Detailed description
quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.
This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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
- primary reconstruction by allograft prosthetic composite
Key exclusion criteria (4 listed)
- resection and reconstruction by prosthesis alone
- resection and reconstruction by prosthesis and cement sleeve reconstruction
- resection and reconstruction by hemiarthroplasty
- 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 |
|---|---|---|
| proximal humeral resection for tumor and allograft prosthetic composite reconstructionallograft prosthetic composite | Procedure or surgery | – |
Primary outcome
Osteolysis (bone stock in cm3)
Time frame: within 3 months post operatively and up to 1 year post operatively
allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up
3 secondary outcomes
Constant score
Time frame: up to 1year post operatively
Complications
Time frame: up to 1year post operatively
Revision
Time frame: up to 1year post operatively
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.
- Individual participant dataSharing planned: No
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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.
Sirveaux FRANCOIS study chair
Central Hopital, 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 4 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?
Osteolysis (bone stock in cm3) (time frame: within 3 months post operatively and up to 1 year post operatively). 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.