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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06316050
• Other study ID #: cst
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 28, 2023

Study information

• Verified date: February 2024
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 28, 2023
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy
• Rotator Cuff Tears

Intervention

Procedure:
• humeral retroversion
REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion

Locations

Country	Name	City	State
Spain	JM MORA	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INTERNAL ROTATION	AT THE SIDE (HAND TO the BACK from CONSTANT TEST)	2 YEARS
Primary	INTERNAL ROTATION	degrees	2 YEARS
Secondary	EXTERNAL ROTATION	degrees	2 YEARS
Secondary	FORWARD ELEVATION	degrees	2 YEARS
Secondary	Simple shoulder test	0-100	2 years
Secondary	Constant test	0-100	2 years
Secondary	ASES test	0-100	2 years
Secondary	Glenoid inclination angle	degrees	2 years
Secondary	glenoid retroversion angle	degrees	2 years
Secondary	abduction	degrees	2 years
Secondary	center of rotation	milimiters	2 years
Secondary	lateralizaiton offset	milimiters	2 years