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OsteoarthritisNCT03573765

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

An observational study of Osteoarthritis and Dislocations, run by University of Oxford.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Shoulder arthroplasty, Elbow arthroplasty and Hand and wrist arthroplasty
How many people
8,308,821 participants
Where
No sites listed yet
Study dates
6 Apr 1998to 5 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients undergoing treatment funded by or in NHS hospitals in England and recorded in the Hospital Episode Statistics Admitted Patient Care database.

Who may be able to join

  • Condition affecting one of:
  • Shoulder
  • Elbow
  • Wrist
  • Hand
  • AND
Show all 16Show fewer
  • 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

Who cannot join

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

About this study

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

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.

Read the 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
  1. 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
  1. 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.

Being tested
Shoulder arthroplasty, Elbow arthroplasty, Hand and wrist arthroplasty, Nerve decompression, Tendon repair
Keywords
epidemiology, upper limb, hand surgery, wrist surgery, shoulder surgery, elbow surgery, outcomes, complications, revision surgery
Medical subject headings
Osteoarthritis, Joint Dislocations, Arthritis, Rotator Cuff Injuries, Shoulder Dislocation, Joint Diseases, Shoulder Fractures, Elbow Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shoulder arthroplastyProcedure or surgery

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

  • Elbow arthroplastyProcedure or surgery

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

  • Hand and wrist arthroplastyProcedure or surgery

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

  • Nerve decompressionProcedure or surgery

    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 repairProcedure or surgery

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

  • Joint stabilisationProcedure or surgery

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

  • Excision/division/release of palmar fasciaProcedure or surgery

    Any procedure performed for treatment of Dupuytren's contracture.

  • Surgical fixation of fracturesProcedure or surgery

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

  • Soft tissue release/debridement/excisionProcedure or surgery

    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 injectionProcedure or surgery

    Any intra-articular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revision and reoperation

    Estimated at annual increments and standardised lifetime risk

    Measured: 1998-2017

  2. Treatment volume: time series

    Crude and adjusted for population by age/sex

    Measured: 1998-2017

  3. Treatment volume: geospatial patterns

    Mapped according to residence and NHS organisation boundaries

    Measured: 1998-2017

Secondary outcomes (4)

  1. Complications

    Death and infection for all. Specific adverse events dependent on procedure, e.g. periprosthetic fracture after arthroplasty surgery

    Measured: 30, 45, 60, 90 days post surgery + 1 year and last recorded follow-up/censoring.

  2. Length of stay post surgery

    Number of days - defined by time elapsed between surgery and the end of NHS spell.

    Measured: up to 52 weeks from date of surgery

  3. Readmission to hospital

    Number of patients readmitted to acute NHS trust

    Measured: up to 30 days following surgery

  4. Healthcare related costs

    Calculated from Healthcare Resource Group codes for index episode and related episodes

    Measured: up to 52 weeks from date of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start6 Apr 1998
  3. Primary completion5 Apr 2017
  4. Study completion5 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
8,308,821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573765
Sponsor's protocol ID
12787
Other IDs
DARS-NIC-29827-Q8Z7Q
Status last verified
Jun 2018
First submitted
4 Jun 2018
Last updated
29 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rees JL, Craig R, Nagra N, Baldwin M, Lane JCE, Price A, Beard DJ, Abram S, Judge A, Prieto-Alhambra D, Furniss D, Carr AJ. Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. BMJ. 2022 Jul 6;378:e069901. doi: 10.1136/bmj-2021-069901.

    PubMed 35938625

  • Alser O, Abram SGF, Craig RS, Lane JCE, Shaw AV, Prats-Uribe A, Rees JL, Prieto-Alhambra D, Furniss D. Temporal Trends and Geographical Variation in Dupuytren Disease Surgery in England: A Population-Based Cohort Study. Ann Plast Surg. 2021 Sep 1;87(3):265-270. doi: 10.1097/SAP.0000000000002734.

    PubMed 34397515

  • Lane JC, Craig R, Rees JL, Gardiner M, Mikhail MM, Riley N, Prieto-Alhambra D, Furniss D. Low rates of serious complications and further procedures following surgery for base of thumb osteoarthritis: analysis of a national cohort of 43 076 surgeries. BMJ Open. 2021 Jul 7;11(7):e045614. doi: 10.1136/bmjopen-2020-045614.

    PubMed 34233971

  • Lane JCE, Craig RS, Rees JL, Gardiner MD, Shaw AV, Spiteri M, Kuo R, Dean BF, Green J, Prieto-Alhambra D, Furniss D. Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4262-4271. doi: 10.1093/rheumatology/keaa925.

    PubMed 33410485

  • Lane JCE, Craig RS, Rees JL, Gardiner MD, Green J, Prieto-Alhambra D, Furniss D. Serious postoperative complications and reoperation after carpal tunnel decompression surgery in England: a nationwide cohort analysis. Lancet Rheumatol. 2020 Sep 30;3(1):e49-e57. doi: 10.1016/S2665-9913(20)30238-1. eCollection 2021 Jan.

    PubMed 33381769

  • Craig RS, Lane JCE, Carr AJ, Furniss D, Collins GS, Rees JL. Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England. BMJ. 2019 Feb 20;364:l298. doi: 10.1136/bmj.l298.

    PubMed 30786996

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Dislocations, run by University of Oxford.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revision and reoperation (time frame: 1998-2017). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573765, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.

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