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

Conditions

• Severe Arthropathy With a Grossly Deficient Rotator Cuff

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Subscapularis repair — PROCEDURE
  Utilizing fiberwire, high tensile strength suture
• Shoulder implant — DEVICE
  Reverse shoulder arthroplasty device

Study Details

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.

Key Dates

Start date

Sep 28, 2018

Status verified

Mar 2022

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Group A
  The subscapularis is repaired. Receives device
• Other: Group B
  The subscapularis is not repaired. Receives device

Primary Outcome Measure

Change in isometric and isokinetic internal rotational strength of abductors [ Time Frame: 6 months, and 1, 2, 5 and 10 years ]

Locations (4)

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