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

NCT ID: NCT03573765

Last Updated: 2018-06-29

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

8308821 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-04-06

Study Completion Date

2017-04-05

Brief Summary

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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

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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.

Conditions

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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

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epidemiology upper limb hand surgery wrist surgery shoulder surgery elbow surgery outcomes complications revision surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Shoulder arthroplasty

Any form of joint replacement of the glenohumeral joint including prosthetic and excision.

Intervention Type PROCEDURE

Elbow arthroplasty

Any form of joint replacement of the elbow joint including prosthetic and excision.

Intervention Type PROCEDURE

Hand and wrist arthroplasty

Any form of joint replacement of joints of the hand and wrist including prosthetic and excision.

Intervention Type PROCEDURE

Nerve decompression

Open or endoscopic release of peripheral nerve entrapment - subdivided by anatomical site of compression. Specific subgroups will include carpal tunnel and cubital tunnel release.

Intervention Type PROCEDURE

Tendon repair

Open or arthroscopic repair or reconstruction of tendons of the shoulder, hand and upper limb in general.

Intervention Type PROCEDURE

Joint stabilisation

Any procedure designed to increase stability of a joint, including soft tissue and bony blocking procedures.

Intervention Type PROCEDURE

Excision/division/release of palmar fascia

Any procedure performed for treatment of Dupuytren's contracture.

Intervention Type PROCEDURE

Surgical fixation of fractures

Any internal or external fixation of upper limb fractures - analysed by anatomical site.

Intervention Type PROCEDURE

Soft tissue release/debridement/excision

Any removal or release of soft tissue for treatment of stiffness, functional impairment or pain. Specific subgroups will include trigger finger release, subacromial surgery and surgery for frozen shoulder.

Intervention Type PROCEDURE

Intra-articular injection

Any intra-articular injection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Arthritis Research UK

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominic Furniss, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

References

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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.

Reference Type DERIVED
PMID: 35938625 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34397515 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34233971 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33410485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33381769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30786996 (View on PubMed)

Other Identifiers

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DARS-NIC-29827-Q8Z7Q

Identifier Type: OTHER

Identifier Source: secondary_id

12787

Identifier Type: -

Identifier Source: org_study_id