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NCT Number: NCT03573765

Epidemiology and Outcomes of Upper Limb Surgery: 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.

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Key information

Conditions

Osteoarthritis Arm Injuries Arthritis Arthropathy Unspecified, Involving Hand Avascular Necrosis Bone Diseases Connective Tissue Diseases Contracture Dislocations Dupuytren Contracture Elbow Arthropathy Elbow Fractures Elbow Injuries Fibroma Fracture Elbow Fracture Wrist and Hand Fracture, Shoulder Fractures, Bone Impingement Syndrome, Shoulder Inflammatory Arthritis Joint Diseases Joint Dislocations Muscular Diseases Musculoskeletal Diseases Necrosis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rotator Cuff Injuries Rotator Cuff Tear Rupture Shoulder Arthropathy Shoulder Dislocation Shoulder Fractures Shoulder Impingement Syndrome Shoulder Injuries Skin and Connective Tissue Diseases Tendinopathy Tendon Entrapment Tendon Injuries Trigger Digit Trigger Finger Disorder Upper Limb Nerve Lesion Wounds and Injuries Wrist Arthropathy Wrist Fractures Wrist Injuries

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • Baseline demographics by procedure type
  • Procedure volume incidence trends
  • Time series analysis
  • Adjusted to standard population distributions
  • Geographical mapping including adjustment for sociodemographic indices including indices of deprivation
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Condition affecting one of:
  • Shoulder
  • Elbow
  • Wrist
  • Hand

AND

  • 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

  • Any arthroplasty surgery using a prosthesis

Exclusion criteria

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

Treatment and study plan

Shoulder Arthroplasty

Procedure

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

Elbow arthroplasty

Procedure

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

Hand and wrist arthroplasty

Procedure

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

Nerve Decompression

Procedure

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

Tendon repair

Procedure

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

Joint stabilisation

Procedure

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

Excision/division/release of palmar fascia

Procedure

Any procedure performed for treatment of Dupuytren's contracture.

Surgical fixation of fractures

Procedure

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

Soft tissue release/debridement/excision

Procedure

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.

intra-articular injection

Procedure

Any intra-articular injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2018
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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