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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03573765
Enrollment
8308821
Registered
2018-06-29
Start date
1998-04-06
Completion date
2017-04-05
Last updated
2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREShoulder arthroplasty

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

PROCEDUREElbow arthroplasty

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

PROCEDUREHand and wrist arthroplasty

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

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

PROCEDURETendon repair

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

PROCEDUREJoint stabilisation

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

PROCEDUREExcision/division/release of palmar fascia

Any procedure performed for treatment of Dupuytren's contracture.

PROCEDURESurgical fixation of fractures

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

PROCEDURESoft 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.

Any intra-articular injection

Sponsors

Wellcome Trust
CollaboratorOTHER
National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Arthritis Research UK
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Revision and reoperation1998-2017Estimated at annual increments and standardised lifetime risk
Treatment volume: time series1998-2017Crude and adjusted for population by age/sex
Treatment volume: geospatial patterns1998-2017Mapped according to residence and NHS organisation boundaries

Secondary

MeasureTime frameDescription
Complications30, 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
Healthcare related costsup to 52 weeks from date of surgeryCalculated from Healthcare Resource Group codes for index episode and related episodes
Length of stay post surgeryup to 52 weeks from date of surgeryNumber of days - defined by time elapsed between surgery and the end of NHS spell.
Readmission to hospitalup to 30 days following surgeryNumber of patients readmitted to acute NHS trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026