Impact of Humeral Component Version on Outcomes Following RTSA

William Beaumont Hospitals

Status: Completed

Conditions: Rotator Cuff Tear Arthropathy

Treatments: Device: 0 degrees humeral component version; Device: 30 degrees humeral component retroversion

Study type: Interventional

Funder types: Other

Identifiers

NCT03111147

2017-057

Details and patient eligibility

About

The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Full description

Retrospective clinical evidence suggests that increasing humeral component retroversion does not affect measured internal or external rotation, however patients with neutral version may experience better function with daily activities requiring internal rotation compared to those with 30 degrees of retroversion. Prospective data on clinical outcomes comparing different humeral component versions in RTSA is currently lacking. The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder arthroplasty.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary reverse total shoulder arthroplasty
• Diagnosis of cuff tear arthropathy or primary OA with RCT
• Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
• 18 years or older

Exclusion criteria

• Revision arthroplasty

• Diagnosis of rheumatoid arthritis, infection, acute trauma or instability

• Minors (under 18 years of age)

  • Prior open shoulder surgery
  • Concomitant latissimus dorsi transfer
  • Patients not undergoing a standard of care physical therapy protocol
  • Pregnant, patient-reported
  • Cognitively impaired

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

0 degrees humeral component version

Experimental group

Description:

Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version

Treatment:

Device: 0 degrees humeral component version

30 degrees humeral component retroversion

Experimental group

Description:

Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion

Treatment:

Device: 30 degrees humeral component retroversion