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

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ClinicalTrials.gov Identifier: NCT03573765
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Arthritis Research UK
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment
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 Procedure: Shoulder arthroplasty Procedure: Elbow arthroplasty Procedure: Hand and wrist arthroplasty Procedure: Nerve decompression Procedure: Tendon repair Procedure: Joint stabilisation Procedure: Excision/division/release of palmar fascia Procedure: Surgical fixation of fractures Procedure: Soft tissue release/debridement/excision Procedure: Intra-articular injection

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.


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Study Type : Observational
Actual Enrollment : 8308821 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 6, 1998
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Shoulder arthroplasty
    Any form of joint replacement of the glenohumeral joint including prosthetic and excision.
  • Procedure: Elbow arthroplasty
    Any form of joint replacement of the elbow joint including prosthetic and excision.
  • Procedure: Hand and wrist arthroplasty
    Any form of joint replacement of joints of the hand and wrist including prosthetic and excision.
  • 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.
  • Procedure: Tendon repair
    Open or arthroscopic repair or reconstruction of tendons of the shoulder, hand and upper limb in general.
  • Procedure: Joint stabilisation
    Any procedure designed to increase stability of a joint, including soft tissue and bony blocking procedures.
  • Procedure: Excision/division/release of palmar fascia
    Any procedure performed for treatment of Dupuytren's contracture.
  • Procedure: Surgical fixation of fractures
    Any internal or external fixation of upper limb fractures - analysed by anatomical site.
  • 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.
  • Procedure: Intra-articular injection
    Any intra-articular injection


Primary Outcome Measures :
  1. Revision and reoperation [ Time Frame: 1998-2017 ]
    Estimated at annual increments and standardised lifetime risk

  2. Treatment volume: time series [ Time Frame: 1998-2017 ]
    Crude and adjusted for population by age/sex

  3. Treatment volume: geospatial patterns [ Time Frame: 1998-2017 ]
    Mapped according to residence and NHS organisation boundaries


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Readmission to hospital [ Time Frame: up to 30 days following surgery ]
    Number of patients readmitted to acute NHS trust

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573765


Sponsors and Collaborators
University of Oxford
Wellcome Trust
National Institute for Health Research, United Kingdom
Arthritis Research UK
Investigators
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Principal Investigator: Dominic Furniss, DPhil University of Oxford

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03573765     History of Changes
Other Study ID Numbers: 12787
DARS-NIC-29827-Q8Z7Q ( Other Identifier: NHS Digital )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
epidemiology
upper limb
hand surgery
wrist surgery
shoulder surgery
elbow surgery
outcomes
complications
revision surgery
Additional relevant MeSH terms:
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Dupuytren Contracture
Arthritis
Joint Dislocations
Joint Diseases
Contracture
Shoulder Dislocation
Trigger Finger Disorder
Necrosis
Fractures, Bone
Rotator Cuff Injuries
Shoulder Fractures
Musculoskeletal Diseases
Wounds and Injuries
Pathologic Processes
Rupture
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases
Tendon Entrapment
Tendinopathy