Arthroscopy Arthrodesis Gleno-humeralDESEPNCT02566382
Preliminary Study of Feasibility of Arthrodesis Scapula-humeral Under Arthroscopy
A study testing arthroscopy arthrodesis of the shoulder in people with Arthroscopy Arthrodesis Gleno-humeral, run by University Hospital, Brest at 1 site in France.
Trial summary
Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopy Arthrodesis Gleno-humeral
- What is being tested?
- arthroscopy arthrodesis of the shoulder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patient having a deficit scapula-humeral mobility
- Impossibility of being operated for a preserving nervous surgery
- Patient affiliation with a social security
- Patient who signed inform consent
Who cannot join
- Patient with No mobility in all the articulations of the shoulder
- Callus malunion of the higher end of the humerus or the glen of the scapula
- Unable to sign an inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility
Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.
Read the detailed description
This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.
- Conditions
- Arthroscopy Arthrodesis Gleno-humeral
- Being tested
- arthroscopy arthrodesis of the shoulder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopy arthrodesis of the shoulderProcedure or surgery
The shoulder surgery will be realized under arthroscopy only
| Study group | Role | What they receive |
|---|---|---|
| shoulder arthroscopy arthrodesis | Experimental | The shoulder surgery will be realized under arthroscopy only. Receives: Procedure: arthroscopy arthrodesis of the shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional
This outcome will be considered like a success if the investigators get a continuous bone matrix between the humeral head and glenoid on the scapula and bone frame continues between the humeral head and the acromion. This evaluation will be done by radiographies.
Measured: 6 months
Secondary outcomes (1)
Blood loss
The blood loss during and after the surgery will be calculated and will be considered like a success if the total blood loss are less than 600ml.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Insufisciency of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopy Arthrodesis Gleno-humeralStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566382
- Sponsor's protocol ID
- RB 12.172 DESEP
- Acronym
- DESEP
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility
- ClinicalTrials.gov ID
- NCT02566382
- Acronym / sponsor ID
- DESEP / RB 12.172 DESEP
- Conditions
- Arthroscopy Arthrodesis Gleno-humeral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufisciency of recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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.
Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.
Detailed description
This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder arthroscopy arthrodesis | Experimental | Procedure: arthroscopy arthrodesis of the shoulderThe shoulder surgery will be realized under arthroscopy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient having a deficit scapula-humeral mobility
- Impossibility of being operated for a preserving nervous surgery
- Patient affiliation with a social security
- Patient who signed inform consent
Key exclusion criteria (3 listed)
- Patient with No mobility in all the articulations of the shoulder
- Callus malunion of the higher end of the humerus or the glen of the scapula
- Unable to sign an inform consent
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 |
|---|---|---|
| arthroscopy arthrodesis of the shoulderThe shoulder surgery will be realized under arthroscopy only | Procedure or surgery | shoulder arthroscopy arthrodesis |
Primary outcome
Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional
Time frame: 6 months
This outcome will be considered like a success if the investigators get a continuous bone matrix between the humeral head and glenoid on the scapula and bone frame continues between the humeral head and the acromion. This evaluation will be done by radiographies.
1 secondary outcome
Blood loss
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Insufisciency of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopy arthrodesis of the shoulder in people with Arthroscopy Arthrodesis Gleno-humeral, run by University Hospital, Brest 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 4 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: stopped early, as of the sponsor's last update on 19 Oct 2017. 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?
The study was stopped early (reason given: Insufisciency of recruitment). 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?
Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional (time frame: 6 months). 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 19 Oct 2017.