A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures
NCT ID: NCT04507880
Last Updated: 2020-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
42 participants
INTERVENTIONAL
2020-08-01
2024-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Outcome and Complications After Global Unite ® Prostheses
NCT03097406
Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.
NCT04431973
Outcomes Following Delta Xtend Reverse Shoulder System
NCT02014350
Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
NCT05447819
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
NCT03806881
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RTSA group
Participants with a complex proximal humerus fracture given a RTSA
Reverse Total Shoulder Arthroplasty
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
Hemiarthroplasty group
Historical cohort of participants, operated with a hemiarthroplasty of the shoulder
Hemiarthroplasty
The shoulder hemiarthroplasty
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Reverse Total Shoulder Arthroplasty
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
Hemiarthroplasty
The shoulder hemiarthroplasty
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
* All patients, regardless of age, with an insufficient or irreparable rotator cuff
Exclusion Criteria
* Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
* Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
* Patients without a Danish civil registration number
65 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Herlev and Gentofte Hospital
OTHER
Signe Rosner Rasmussen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Signe Rosner Rasmussen
MD, orthopedic resident, principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bo S Olsen, Professor
Role: STUDY_CHAIR
Herlev and Gentofte Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
71005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.