Focus on the Humeral Component Following Reverse Shoulder Arthroplasty (RSA)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Rotator Cuff Arthropathy

Treatments: Other: Reverse total shoulder replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04809077

S63831

Details and patient eligibility

About

Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Full description

Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum age of 18 years old
• Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
• Primary indication for surgery is rotator cuff arthropathy
• Informed consent obtained

Exclusion criteria

• Total shoulder replacement in post septic arthritis.
• Total shoulder replacement in post-instability arthritis.
• Revision total shoulder arthroplasty.
• Posttraumatic total shoulder arthroplasty (after failed index operation)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Reverse total shoulder replacement

Other group

Description:

Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)

Treatment:

Other: Reverse total shoulder replacement