NCT03573765

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,308,821

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1998

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 1998

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

19 years

First QC Date

June 4, 2018

Last Update Submit

June 19, 2018

Conditions

Keywords

epidemiologyupper limbhand surgerywrist surgeryshoulder surgeryelbow surgeryoutcomescomplicationsrevision surgery

Outcome Measures

Primary Outcomes (3)

  • Revision and reoperation

    Estimated at annual increments and standardised lifetime risk

    1998-2017

  • Treatment volume: time series

    Crude and adjusted for population by age/sex

    1998-2017

  • Treatment volume: geospatial patterns

    Mapped according to residence and NHS organisation boundaries

    1998-2017

Secondary Outcomes (4)

  • Complications

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

  • Length of stay post surgery

    up to 52 weeks from date of surgery

  • Readmission to hospital

    up to 30 days following surgery

  • Healthcare related costs

    up to 52 weeks from date of surgery

Interventions

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

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

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.

Tendon repairPROCEDURE

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

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

Any procedure performed for treatment of Dupuytren's contracture.

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

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • Any arthroplasty surgery using a prosthesis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

OsteoarthritisJoint DislocationsArthritisRotator Cuff InjuriesShoulder DislocationJoint DiseasesShoulder FracturesElbow FracturesWrist FracturesDupuytren ContractureShoulder Impingement SyndromeTrigger Finger DisorderOsteonecrosis

Interventions

Arthroplasty, Replacement, ShoulderArthroplasty, Replacement, ElbowInjections, Intra-Articular

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesRheumatic DiseasesWounds and InjuriesRuptureShoulder InjuriesTendon InjuriesFractures, BoneElbow InjuriesArm InjuriesWrist InjuriesFibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesTendon EntrapmentTendinopathyBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis ImplantationInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Dominic Furniss, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 29, 2018

Study Start

April 6, 1998

Primary Completion

April 5, 2017

Study Completion

April 5, 2017

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share