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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573765
• Other study ID #: 12787
• Secondary ID: DARS-NIC-29827-Q
• Status: Completed
• Start date: April 6, 1998
• Est. completion date: April 5, 2017

Study information

• Verified date: June 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8308821
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthropathy Unspecified, Involving Hand
• Avascular Necrosis
• Contracture
• Dislocations
• Dupuytren Contracture
• Elbow Arthropathy
• Fracture Elbow
• Fracture Wrist and Hand
• Fracture, Shoulder
• Fractures, Bone
• Impingement Syndrome, Shoulder
• Inflammatory Arthritis
• Joint Diseases
• Necrosis
• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Arthropathy
• Shoulder Dislocation
• Shoulder Fractures
• Trigger Digit
• Trigger Finger Disorder
• Upper Limb Nerve Lesion
• Wrist Arthropathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Oxford	Arthritis Research UK, National Institute for Health Research, United Kingdom, Wellcome Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision and reoperation	Estimated at annual increments and standardised lifetime risk	1998-2017
Primary	Treatment volume: time series	Crude and adjusted for population by age/sex	1998-2017
Primary	Treatment volume: geospatial patterns	Mapped according to residence and NHS organisation boundaries	1998-2017
Secondary	Complications	Death and infection for all. Specific adverse events dependent on procedure, e.g. periprosthetic fracture after arthroplasty surgery	30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.
Secondary	Length of stay post surgery	Number of days - defined by time elapsed between surgery and the end of NHS spell.	up to 52 weeks from date of surgery
Secondary	Readmission to hospital	Number of patients readmitted to acute NHS trust	up to 30 days following surgery
Secondary	Healthcare related costs	Calculated from Healthcare Resource Group codes for index episode and related episodes	up to 52 weeks from date of surgery