Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty

Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears; Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Procedure: humeral retroversion

Detailed Description

Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • JM MORA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
• Good functionality of the deltoid muscle.
• Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
• Accept informed consent

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: humeral retroversion 0º; will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital	Procedure: humeral retroversion; REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion
No Intervention: humeral retroversion 30º; will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
INTERNAL ROTATION	AT THE SIDE (HAND TO the BACK from CONSTANT TEST)	2 YEARS
INTERNAL ROTATION	degrees	2 YEARS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EXTERNAL ROTATION	degrees	2 YEARS
FORWARD ELEVATION	degrees	2 YEARS
Simple shoulder test	0-100	2 years
Constant test	0-100	2 years
ASES test	0-100	2 years
Glenoid inclination angle	degrees	2 years
glenoid retroversion angle	degrees	2 years
abduction	degrees	2 years
center of rotation	milimiters	2 years
lateralizaiton offset	milimiters	2 years

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: cst

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No