Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data

NCT ID: NCT06355011

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3891 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-04-02

Brief Summary

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The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:

* Who are receiving primary total elbow replacement surgery?
* Where and by whom is the total elbow replacement surgery is being performed?
* What the current surgical practices for total elbow replacement?

Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used.

Detailed Description

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Conditions

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Total Elbow Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Total Elbow Replacement

Total elbow replacement is a procedure that involves replacing the elbow joint with an implanted device to alleviate pain and improve function.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients aged 18 to 100 years old with a primary TER on the National Joint Registry (NJR) elbow dataset from the start of data collection on the 1st of April 2012 to the 31st of December 2022 will be included.

Exclusion Criteria

* Patients are excluded if they did not consent for their data to be used for research purposes, if it is impossible to trace them after surgery, if their ID numbers are invalid, or if the surgery was not performed in England.
* Unconfirmed procedures and procedures with inconsistent operative patterns (i.e. a sequence of operations where the primary operation is not the first operation in the sequence or where there are multiple primary operations recorded for the same joint) will be excluded from the analyses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The National Joint Registry

UNKNOWN

Sponsor Role collaborator

The Royal College of Surgeons of England

OTHER

Sponsor Role collaborator

John Charnley Trust

UNKNOWN

Sponsor Role collaborator

University of Bristol

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Zaid Hamoodi

National Joint Registry research fellow and PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Hamoodi Z, Sayers A, Whitehouse MR, Rangan A, Kearsley-Fleet L, Sergeant JC, Watts AC. Total elbow replacement in England: a protocol for analysis of National Joint Registry and Hospital Episode Statistics data. J Orthop Surg Res. 2024 Aug 30;19(1):526. doi: 10.1186/s13018-024-04903-9.

Reference Type DERIVED
PMID: 39215301 (View on PubMed)

Other Identifiers

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7016194

Identifier Type: -

Identifier Source: org_study_id

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