Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 9:56 AM
Study NCT ID:
NCT07060469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.
Sponsor:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Organization:
Study Overview
Official Title:
Comparative Analysis of Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty in Patients Over 70: A Retrospective Single Unit Single Surgeon Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.
Detailed Description:
Despite numerous studies, the literature presents conflicting evidence regarding the comparative effectiveness of anatomic shoulder arthroplasty (aTSA) versus reverse shoulder arthroplasty in primary humeral osteoarthritis among patients aged over 70 years.
There is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.
This retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis.
There is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.
This retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RL1 905 | OTHER | The Robert Jones and Agnes Hunt Orthopaedic Hospital | View |