Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

NCT04809077 | Completed

• 1 other identifier: S63831
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Arthropathy

Keywords

Reverse total shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• Shoulder X-ray

  To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al.

  up to 20 months

Secondary Outcomes (5)

• Clinical outcome

  up to 20 months

• Constant-Murley score

  up to 20 months

• Short Form 36 Health Survey Questionnaire (SF-36)

  up to 20 months

• Net Promotor Score (NPS)

  one time visit

• Anchor Question Shoulder Score

  up to 20 months

Study Arms (1)

Reverse total shoulder replacement

OTHER

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

Other: Reverse total shoulder replacement

Interventions

Reverse total shoulder replacement OTHER

Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

Reverse total shoulder replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Philippe Debeer

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)