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The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty

NCT03711175 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-03-22

No results posted yet for this study

Summary

The study is a prospective, multi-center, randomized blinded study to determine how repairing the subscapularis vs. not repairing the subscapularis when subjects are implanted with the AltiVate Reverse® Shoulder System for reverse total shoulder arthroplasty affects isometric and isokinetic internal rotational strength. It is hypothesized that patients in which the subscapularis is repaired will have improved postoperative isometric and isokinetic internal rotational strength.

Conditions

  • Severe Arthropathy With a Grossly Deficient Rotator Cuff

Interventions

PROCEDURE

Subscapularis repair

Utilizing fiberwire, high tensile strength suture

DEVICE

Shoulder implant

Reverse shoulder arthroplasty device

Sponsors & Collaborators

  • Encore Medical, L.P.

    lead INDUSTRY

Principal Investigators

  • Jessica Knowlton, MS, CRA · DJO Global

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03711175 on ClinicalTrials.gov