Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data

June 19, 2018 updated by: University of Oxford

The Role of Patient Factors, Surgical Factors and Hospital Factors Upon Patient Outcomes and NHS Costs in the Treatment of Upper Limb Musculoskeletal Conditions: Spatial and Iongitudinal Analysis of Routine Data

Surgery is a common treatment type for damaged joints, tendons and nerves in the upper limb where conservative measures are inappropriate or have failed. These conditions are common and result in significant levels of pain and functional disability. The investigators are conducting a broad ranging study of variation in the provision of surgical treatment and factors affecting outcomes after surgical treatment of upper limb conditions. This will be a population-based study of all patients undergoing surgical treatment funded by the National Health Service (NHS) of England over a nineteen-year period. This study will help to understand the factors associated with a poor outcome following surgery, which can be shared with patients considering treatment options. The investigators will also document current and future health service burden associated with commonly performed surgical procedures including complications and repeat operations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct time series analyses, geospatial mapping and risk-factor association studies for both access to and outcomes of surgical treatments of the upper limbs. A large cohort of pseudonymised records will be extracted from the NHS Hospital Episode Statistics Admitted Patient Care database. Suitable patients will be identified based on a match to a specified list of International Classification of Diseases (ICD-10) and Office for Population Censuses and Surveys (OPCS-4) codes. Dates and cause of death will be linked from the Office for National Statistics (ONS) by NHS Digital.

Separate analyses will be conducted for different intervention types with detailed outcomes reporting for high volume procedures. Adults will be defined as those aged 18 years or older at the time of surgery. Children will be defined as those aged less than 18 years at surgery and only included in a limited number of analyses where relevant (e.g. trigger digit).

Key analyses:

  1. Baseline demographics by procedure type

  2. Procedure volume incidence trends

    • Time series analysis
    • Adjusted to standard population distributions
    • Geographical mapping including adjustment for sociodemographic indices including indices of deprivation

  3. Revision, reoperation and mortality rates:

    • Estimation by Kaplan Meier and actuarial life table methods
    • Life time risk calculated by the cumulative probability method
    • Cox regression adjusted for comorbidities and demographic, social and geographic factors

  4. Complications, length of stay, costs:

    • Logistic and linear regression models for binary and continuous outcomes respectively
    • Adjusted for comorbidities and demographic, social and geographic factors

Where appropriate, the impact of replacing missing data will be explored with use of multiple imputation. All suitable patients will be entered into analyses to maximise statistical efficiency.

Study Type

Observational

Enrollment (Actual)

8308821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing treatment funded by or in NHS hospitals in England and recorded in the Hospital Episode Statistics Admitted Patient Care database.

Description

Inclusion Criteria:

  1. Condition affecting one of:

    • Shoulder
    • Elbow
    • Wrist
    • Hand

    AND

  2. All patients treated with surgery for any of the following:

    • Osteoarthritis
    • Inflammatory arthritis
    • Any other cause of arthropathy
    • Tendon tears
    • Peripheral neuropathy
    • Fractures and/or dislocations
    • Instability

    OR

  3. Any arthroplasty surgery using a prosthesis

Exclusion Criteria:

  • Patients registering a "type 2 opt out" - withholding NHS data from research use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision and reoperation
Time Frame: 1998-2017
Estimated at annual increments and standardised lifetime risk
1998-2017
Treatment volume: time series
Time Frame: 1998-2017
Crude and adjusted for population by age/sex
1998-2017
Treatment volume: geospatial patterns
Time Frame: 1998-2017
Mapped according to residence and NHS organisation boundaries
1998-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.
Death and infection for all. Specific adverse events dependent on procedure, e.g. periprosthetic fracture after arthroplasty surgery
30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.
Length of stay post surgery
Time Frame: up to 52 weeks from date of surgery
Number of days - defined by time elapsed between surgery and the end of NHS spell.
up to 52 weeks from date of surgery
Readmission to hospital
Time Frame: up to 30 days following surgery
Number of patients readmitted to acute NHS trust
up to 30 days following surgery
Healthcare related costs
Time Frame: up to 52 weeks from date of surgery
Calculated from Healthcare Resource Group codes for index episode and related episodes
up to 52 weeks from date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Wellcome Trust
National Institute for Health Research, United Kingdom
Arthritis Research UK

Investigators

  • Principal Investigator: Dominic Furniss, DPhil, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 1998

Primary Completion (Actual)

April 5, 2017

Study Completion (Actual)

April 5, 2017

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12787
  • DARS-NIC-29827-Q8Z7Q (Other Identifier: NHS Digital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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