Clinical trial NCT04809077: Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
Official title: Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Arthropathy
Keywords: Reverse total shoulder arthroplasty
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Shoulder X-ray
timeFrame: up to 20 months
Secondary outcomes:
measure: Clinical outcome
timeFrame: up to 20 months
measure: Constant-Murley score
timeFrame: up to 20 months
measure: Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: up to 20 months
measure: Net Promotor Score (NPS)
timeFrame: one time visit
measure: Anchor Question Shoulder Score
timeFrame: up to 20 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Philippe Debeer
role: PRINCIPAL_INVESTIGATOR
References: