Prognostic Factors Associated With Failure of Total Elbow Replacement

NCT06760585 | Not Yet Recruiting

• 1 other identifier: 7271373
• Study Type: observational
• Target: 4,073
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to evaluate potential prognostic factors for TER failure . The National Joint Registry (NJR) currently contains the largest elbow registry dataset in the world, which has been shown to have high completeness and accuracy. In order to incorporate additional potential prognostic factors not captured in the NJR, this study will combine the NJR elbow dataset with the NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC) data. Understanding prognostic factors is a crucial step for informing the development of strategies aimed at minimising the risk of failure and the necessity for additional surgery, which poses a burden on patients and society.

Conditions

Total Elbow Replacement

Outcome Measures

Primary Outcomes (1)

• The hazard of failure of total elbow replacement

  Indicated by the need for revision surgery recorded on the NJR. The NJR's definition of "revision surgery" will be used, which encompasses any operation involving the addition, removal, or modification of one or more components in a joint replacement. This includes debridement, antibiotics, and implant retention (DAIR) with modular exchange procedures.

  11 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 16 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 2023 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, Kearsley-Fleet L, Sergeant JC, Watts AC. Prognostic factors associated with failure of total elbow replacement: a protocol for analysis of National Joint Registry data in England. BMJ Open. 2025 Jul 1;15(7):e098729. doi: 10.1136/bmjopen-2025-098729.

  PMID: 40592743 DERIVED

Central Study Contacts

Zaid Hamoodi, MBChB MSc

CONTACT

07533704775; Zaid.hamoodi-2@postgrad.manchester.ac.uk

Study Design

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

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: January 15, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)