Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data
|ClinicalTrials.gov Identifier: NCT03573765|
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
|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|
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).
- 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.
|Study Type :||Observational|
|Actual Enrollment :||8308821 participants|
|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|
- 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
- Revision and reoperation [ Time Frame: 1998-2017 ]Estimated at annual increments and standardised lifetime risk
- Treatment volume: time series [ Time Frame: 1998-2017 ]Crude and adjusted for population by age/sex
- Treatment volume: geospatial patterns [ Time Frame: 1998-2017 ]Mapped according to residence and NHS organisation boundaries
- 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
- 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.
- Readmission to hospital [ Time Frame: up to 30 days following surgery ]Number of patients readmitted to acute NHS trust
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573765
|Principal Investigator:||Dominic Furniss, DPhil||University of Oxford|