Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04809077
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Arthropathy	Other: Reverse total shoulder replacement	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Reverse total shoulder replacement Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)	Other: Reverse total shoulder replacement; Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. Constant-Murley score [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) [up to 20 months]

   To indicate the health status and pain scales

4. Net Promotor Score (NPS) [one time visit]

   To evaluate patient satisfaction after surgery

5. Anchor Question Shoulder Score [up to 20 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT04809077
• Other Study ID Numbers: S63831
• First Posted: Mar 22, 2021
• Last Update Posted: Jul 15, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitaire Ziekenhuizen Leuven: Reverse total shoulder arthroplasty
• Additional relevant MeSH terms: Joint Diseases

Study Results

No Results Posted as of Jul 15, 2021