Rotator Cuff Arthropathy
Conditions
Keywords
Reverse total shoulder arthroplasty
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.
Interventions
Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder X-ray | up to 20 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | up to 20 months | To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome |
| Constant-Murley score | up to 20 months | To evaluate the functional state of the shoulder in patients with shoulder complaints |
| Short Form 36 Health Survey Questionnaire (SF-36) | up to 20 months | To indicate the health status and pain scales |
| Net Promotor Score (NPS) | one time visit | To evaluate patient satisfaction after surgery |
| Anchor Question Shoulder Score | up to 20 months | To measure the change in general daily functioning and pain symptoms after shoulder surgery |
Countries
Belgium
Outcome results
None listed