Clinical trial NCT03573765: Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Dislocations
Inflammatory Arthritis
Rotator Cuff Tear
Shoulder Dislocation
Upper Limb Nerve Lesion
Shoulder Arthropathy
Elbow Arthropathy
Wrist Arthropathy
Arthropathy Unspecified, Involving Hand
Fracture, Shoulder
Fracture Elbow
Fracture Wrist and Hand
Dupuytren Contracture
Impingement Syndrome, Shoulder
Trigger Digit
Avascular Necrosis
Keywords: epidemiology
upper limb
hand surgery
wrist surgery
shoulder surgery
elbow surgery
outcomes
complications
revision surgery
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
name: Arthritis Research UK
First posted: 2018-06-29
Enrollment: 8308821
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Revision and reoperation
timeFrame: 1998-2017
measure: Treatment volume: time series
timeFrame: 1998-2017
measure: Treatment volume: geospatial patterns
timeFrame: 1998-2017
Secondary outcomes:
measure: Complications
timeFrame: 30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.
measure: Length of stay post surgery
timeFrame: up to 52 weeks from date of surgery
measure: Readmission to hospital
timeFrame: up to 30 days following surgery
measure: Healthcare related costs
timeFrame: up to 52 weeks from date of surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Dominic Furniss, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rees JL, Craig R, Nagra N, Baldwin M, Lane JCE, Price A, Beard DJ, Abram S, Judge A, Prieto-Alhambra D, Furniss D, Carr AJ. Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. BMJ. 2022 Jul 6;378:e069901. doi: 10.1136/bmj-2021-069901.
citation: Alser O, Abram SGF, Craig RS, Lane JCE, Shaw AV, Prats-Uribe A, Rees JL, Prieto-Alhambra D, Furniss D. Temporal Trends and Geographical Variation in Dupuytren Disease Surgery in England: A Population-Based Cohort Study. Ann Plast Surg. 2021 Sep 1;87(3):265-270. doi: 10.1097/SAP.0000000000002734.
citation: Lane JC, Craig R, Rees JL, Gardiner M, Mikhail MM, Riley N, Prieto-Alhambra D, Furniss D. Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis: analysis of a national cohort of 43 076 surgeries. BMJ Open. 2021 Jul 7;11(7):e045614. doi: 10.1136/bmjopen-2020-045614.
citation: Lane JCE, Craig RS, Rees JL, Gardiner MD, Shaw AV, Spiteri M, Kuo R, Dean BF, Green J, Prieto-Alhambra D, Furniss D. Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4262-4271. doi: 10.1093/rheumatology/keaa925.
citation: Lane JCE, Craig RS, Rees JL, Gardiner MD, Green J, Prieto-Alhambra D, Furniss D. Serious postoperative complications and reoperation after carpal tunnel decompression surgery in England: a nationwide cohort analysis. Lancet Rheumatol. 2020 Sep 30;3(1):e49-e57. doi: 10.1016/S2665-9913(20)30238-1. eCollection 2021 Jan.
citation: Craig RS, Lane JCE, Carr AJ, Furniss D, Collins GS, Rees JL. Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England. BMJ. 2019 Feb 20;364:l298. doi: 10.1136/bmj.l298.