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Completed

NCT Number: NCT04809077

Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

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.

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Key information

Conditions

Rotator Cuff Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Reverse total shoulder replacement

Other

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

Primary outcomes

  1. Shoulder X-ray

    Time frame: 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 outcomes

  1. Clinical outcome

    Time frame: 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

  2. Constant-Murley score

    Time frame: up to 20 months

    To evaluate the functional state of the shoulder in patients with shoulder complaints

  3. Short Form 36 Health Survey Questionnaire (SF-36)

    Time frame: up to 20 months

    To indicate the health status and pain scales

  4. Net Promotor Score (NPS)

    Time frame: one time visit

    To evaluate patient satisfaction after surgery

  5. Anchor Question Shoulder Score

    Time frame: up to 20 months

    To measure the change in general daily functioning and pain symptoms after shoulder surgery

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings

Acronym: RSA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2021
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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