Prosthetic ArthroplastiesNCT04418050
Prosthetic Arthroplasties in Weight-bearing Shoulders
An observational study of Prosthetic Arthroplasties, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Arthroplasties
- What is being tested?
- Shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2010to 1 Sep 2016
- 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: patients not walking or rarely walking, long-term users of a wheelchair
Who may be able to join
- patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis
Who cannot join
- Patient walking without aid
- Shoulder surgery other than arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use
Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.
- Conditions
- Prosthetic Arthroplasties
- Being tested
- Shoulder arthroplasty
- Keywords
- paraplegia, Shoulder prosthesis, spinal cord injury, wheelchair
- Medical subject headings
- Paraplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder arthroplastyProcedure or surgery
Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of joint mobility
Evolution of joint mobility
Measured: 1 day
Secondary outcomes (1)
number of searches for early implant loosening
number of searches for early implant loosening
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Feb 2010
- Primary completion1 Feb 2010
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic ArthroplastiesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léo Chiche, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418050
- Sponsor's protocol ID
- RECHMPL20_0200
- Status last verified
- Mar 2020
- First submitted
- 17 Apr 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use
- ClinicalTrials.gov ID
- NCT04418050
- Acronym / sponsor ID
- RECHMPL20_0200
- Conditions
- Prosthetic Arthroplasties
- Keywords
- paraplegia, Shoulder prosthesis, spinal cord injury, wheelchair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 1 Feb 2010 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 5 Jun 2020 (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.
Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.
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
- patients not walking or rarely walking, long-term users of a wheelchair
Key inclusion criteria (1 listed)
- patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis
Key exclusion criteria (2 listed)
- Patient walking without aid
- Shoulder surgery other than arthroplasty
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 |
|---|---|---|
| Shoulder arthroplastySurgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis | Procedure or surgery | – |
Primary outcome
Evolution of joint mobility
Time frame: 1 day
Evolution of joint mobility
1 secondary outcome
number of searches for early implant loosening
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Léo Chiche, MD principal investigator
University Hospital, Montpellier
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 Prosthetic Arthroplasties, run by University Hospital, Montpellier 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jun 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of joint mobility (time frame: 1 day). 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 5 Jun 2020.