- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418050
Prosthetic Arthroplasties in Weight-bearing Shoulders
June 4, 2020 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients not walking or rarely walking, long-term users of a wheelchair
Description
Inclusion criteria:
- 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
Exclusion criteria:
- Patient walking without aid
- Shoulder surgery other than arthroplasty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of joint mobility
Time Frame: 1 day
|
Evolution of joint mobility
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of searches for early implant loosening
Time Frame: 1 day
|
number of searches for early implant loosening
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Léo Chiche, MD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 17, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 5, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2020
Last Update Submitted That Met QC Criteria
June 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL20_0200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prosthetic Arthroplasties
-
Stryker South PacificCompletedKnee Replacement | Arthroplasties
-
Molnlycke Health Care ABCompletedArthroplasties, Hip Replacement | Arthroplasties, Knee ReplacementUnited States
-
Hospital District of Helsinki and UusimaaUniversity of Turku; Karlstad UniversityCompletedArthroplasties, Hip Replacement | Arthroplasties, Knee ReplacementFinland
-
Smith & Nephew, Inc.TerminatedArthroplasties, Hip ReplacementUnited States, Belgium, Canada
-
CorinActive, not recruitingArthroplasties, Knee ReplacementUnited States
-
Washington University School of MedicineStryker NordicCompletedArthroplasties, Knee ReplacementUnited States
-
Stryker South PacificCompletedArthroplasties, Replacement, Knee
-
University of Colorado, DenverNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting
-
University of AarhusEnrolling by invitationArthroplasties, Hip ReplacementDenmark
-
Stryker South PacificCompletedArthroplasties, Replacement, Knee
Clinical Trials on Shoulder arthroplasty
-
Ottawa Hospital Research InstituteRecruiting
-
Washington University School of MedicineZimmer BiometTerminated
-
University of AlbertaCanadian Orthopaedic Foundation; University Hospital FoundationRecruitingShoulder OsteoarthritisCanada
-
Stryker Trauma GmbHTerminatedArthroplasty | Hemiarthroplasty | Shoulder PainUnited States
-
Ottawa Hospital Research InstituteRecruitingOsteoarthritis ShoulderCanada
-
Centre Hospitalier Universitaire de NiceRecruitingArthroplasty ComplicationsFrance
-
Herlev and Gentofte HospitalRecruitingGlenohumeral OsteoarthritisDenmark
-
Consorci Sanitari de l'AnoiaParc de Salut Mar; Germans Trias i Pujol HospitalCompleted
-
FX SolutionsRecruitingShoulder Fractures | Shoulder Disease | Shoulder Arthroplasty for Revision of Previous TreatmentMonaco, France
-
Lovisenberg Diakonale HospitalHaukeland University Hospital; Sykehuset Telemark; University Hospital, AkershusRecruitingShoulder Osteoarthritis | Arthroplasty, Replacement, ShoulderNorway