Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty
1 other identifier
interventional
60
1 country
1
Brief Summary
Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2023
CompletedFirst Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedMarch 18, 2024
February 1, 2024
3.1 years
January 16, 2024
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
INTERNAL ROTATION
AT THE SIDE (HAND TO the BACK from CONSTANT TEST)
2 YEARS
INTERNAL ROTATION
degrees
2 YEARS
Secondary Outcomes (10)
EXTERNAL ROTATION
2 YEARS
FORWARD ELEVATION
2 YEARS
Simple shoulder test
2 years
Constant test
2 years
ASES test
2 years
- +5 more secondary outcomes
Study Arms (2)
humeral retroversion 0º
ACTIVE COMPARATORwill be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital
humeral retroversion 30º
NO INTERVENTIONwill be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital
Interventions
REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion
Eligibility Criteria
You may qualify if:
- Good functionality of the deltoid muscle.
- Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
- Accept informed consent
You may not qualify if:
- \- Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
- Fracture of shoulder in the upper extremity to intervene.
- Central neurological diseases
- Advanced cognitive impairment
- Brachial plexus injuries
- Local or systemic infection.
- Oncological disease
- Treatment with immunosuppressants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
JM MORA
Terrassa, Barcelona, 08227, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Open randomized controlled clinical trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Shoulder Unit
Study Record Dates
First Submitted
January 16, 2024
First Posted
March 18, 2024
Study Start
August 1, 2018
Primary Completion
August 31, 2021
Study Completion
June 28, 2023
Last Updated
March 18, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR