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

NCT06355011 | Completed

• 1 other identifier: 7016194
• Study Type: observational
• Target: 3,891
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Elbow Replacement

Outcome Measures

Primary Outcomes (1)

• The incidence of total elbow replacement (TER) in England

  The number and age-sex standardised rate of TER for different sexes, ethnicities, and socioeconomic backgrounds.

  Yearly (1 year) incidence for a 10 year period

Secondary Outcomes (5)

• Serious adverse events or re-admissions

  30 and 90 days after the index TER

• Duration of elective wait

  Up to 10 years period

• Post-operative duration of stay

  Up to 10 years period

• Surgeon volume

  10 year (2012 to 2022)

• Hospital volume

  10 year (2012 to 2022)

Other Outcomes (16)

• Patient characteristics (Age)

  10 year (2012 to 2022)

• Body mass index

  10 year (2012 to 2022)

• Hand dominance

  10 year (2012 to 2022)

Interventions

Total Elbow Replacement DEVICE

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a primary total elbow replacement in England on the National Joint Registry (NJR)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• The National Joint Registry: collaborator
• The Royal College of Surgeons of England: collaborator
• John Charnley Trust: collaborator
• University of Bristol: collaborator

Study Sites (1)

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

Manchester, M13 9PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39215301 DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Elbow

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Joint Registry research fellow and PhD Student

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: March 1, 2024
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)