Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000005156
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
8/01/2019
Date last updated
24/01/2020
Date data sharing statement initially provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Barwon Joint Replacement Registry
Scientific title
Barwon Joint Replacement Registry: a prospective database for evaluating outcomes of joint replacement
Secondary ID [1] 296716 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip replacement surgery
310568 0
Knee replacement surgery 310662 0
Elbow replacement surgery 310663 0
Shoulder replacement surgery 310664 0
Condition category
Condition code
Musculoskeletal 309281 309281 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients undergoing hip, knee, shoulder or elbow arthroplasty at Barwon Health or SJOG are eligible for inclusion in the study.

Post-operative follow-up procedures vary between Barwon Health and SJOG.

At Barwon Health, study participants will be assessed in-person at University Hospital Geelong (UHG) 3-6 months following the operation. Participants will then be assessed via mail-out at 1 year, 5 years and 8 years post-op and then biennially thereafter. Participants with complications or suspected complications identified via mail-out will be invited to the UHG for in-person review.

At SJOG, study participants will be assessed via mail-out at 12 months following the operation. Patients will also undergo clinical review with their surgeon at intervals decided by the surgeon, which is not considered part of the registry.

Data will be collected with paper-based or electronic assessment tools and entered into the Standardised Orthopaedic Clinical Research and Treatment Evaluation Software (Socrates) or the REDCap data management tool hosted by Barwon Health.

Outcome measures include, where relevant:
Shoulders: Constant Shoulder Score, Oxford Shoulder Score, Quick Dash.
Hips: Oxford Hip Score, WOMAC, MAPT
Knees: Oxford Knee Score, Knee Society Score, WOMAC, MAPT
Elbows: Mayo Elbow Score, Quick Dash, ASES Elbow Assessment Score
All joints: EuroQolED-5D, Patient Satisfaction/VAS, global assessment of change.

Demographic information such as age, gender, weight, height, educational level, employment status and comorbidities will also be collected. Operative details such as prosthesis type will also be collected.
Intervention code [1] 313022 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308256 0
Evaluate pain following joint replacement undertaken at Barwon Health and SJOG, via study-specific questionnaire.
Timepoint [1] 308256 0
12 months post-operatively
Secondary outcome [1] 354428 0
Evaluate physical function following joint replacement undertaken at Barwon Health and SJOG, via study specific questionnaire for the appropriate joint e.g. Constant Shoulder Score, Oxford Shoulder Score, Quick Dash, Oxford Hip Score, WOMAC, MAPT, Oxford Knee Score, Knee Society Score, WOMAC, MAPT, Mayo Elbow Score, Quick Dash, ASES Elbow Assessment Score, EuroQolED-5D, Patient Satisfaction/VAS
Timepoint [1] 354428 0
12 months post-operatively
Secondary outcome [2] 354441 0
Evaluate quality of life following joint replacement undertaken at Barwon Health and SJOG, assessed via study specific questionnaire e.g. EuroQol ED-5D, Patient Satisfaction/VAS.
Timepoint [2] 354441 0
12 months post-operatively
Secondary outcome [3] 354442 0
Evaluate pain 5 years or more joint replacement surgery for Barwon Health patients via survey-specific questionnaire for the appropriate joint e.g. Constant Shoulder Score, Oxford Shoulder Score, Quick Dash, Oxford Hip Score, WOMAC, MAPT, Oxford Knee Score, Knee Society Score, WOMAC, MAPT, Mayo Elbow Score, Quick Dash, ASES Elbow Assessment Score, EuroQol ED-5D, Patient Satisfaction/VAS.
Timepoint [3] 354442 0
5 years, 8 years and biennially thereafter for during of patient lifetime, post joint replacement surgery
Secondary outcome [4] 354443 0
Evaluate physical function 5 years or more after joint replacement surgery for Barwon Health patients, via study specific questionnaire for the appropriate joint e.g. Constant Shoulder Score, Oxford Shoulder Score, Quick Dash, Oxford Hip Score, WOMAC, MAPT, Oxford Knee Score, Knee Society Score, WOMAC, MAPT, Mayo Elbow Score, Quick Dash, ASES Elbow Assessment Score
Timepoint [4] 354443 0
5 years, 8 years and biennially thereafter for during of patient lifetime, post joint replacement surgery
Secondary outcome [5] 354444 0
Evaluate quality of life 5 years or more after joint replacement surgery for Barwon Health patients, via study-specific questionnaires e.g. EuroQol ED-5D, Patient Satisfaction/VAS.
Timepoint [5] 354444 0
5 years, 8 years and biennially thereafter for during of patient lifetime, post joint replacement surgery

Eligibility
Key inclusion criteria
All patients undergoing hip, knee, shoulder or elbow arthroplasty at Barwon Health or SJOG are eligible for inclusion in the study.

Eligible participants will be included in the Barwon Health and SJOG Registries unless they opt out.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis is primarily descriptive. More detailed analysis is study specific using population and prosthesis variables and techniques such as ANOVA and Caplan-Meyer survivorship.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/1988
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50000
Accrual to date
11500
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12555 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 12556 0
St John of God Hospita, Geelong - Geelong
Recruitment postcode(s) [1] 24935 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 301296 0
Hospital
Name [1] 301296 0
Barwon Health
Country [1] 301296 0
Australia
Funding source category [2] 301297 0
Hospital
Name [2] 301297 0
St John of God Hospital Geelong
Country [2] 301297 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Bellerine Street, Geelong, Victoria 3220
PO Box 281
Country
Australia
Secondary sponsor category [1] 300948 0
Hospital
Name [1] 300948 0
St John of God Hospital Geelong
Address [1] 300948 0
80 Myers St, Geelong Victoria 3220
Country [1] 300948 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302037 0
Barwon Health Ethics Committee
Ethics committee address [1] 302037 0
Bellerine Street Geelong, Victoria 3220
PO Box 281
Ethics committee country [1] 302037 0
Australia
Date submitted for ethics approval [1] 302037 0
Approval date [1] 302037 0
24/05/2013
Ethics approval number [1] 302037 0
Ethics committee name [2] 302089 0
St John of God Human Research Ethics Commitee
Ethics committee address [2] 302089 0
50 Myers Street Geelong, Victoria 3220
Ethics committee country [2] 302089 0
Australia
Date submitted for ethics approval [2] 302089 0
Approval date [2] 302089 0
31/08/2018
Ethics approval number [2] 302089 0

Summary
Brief summary
The primary aim of the Barwon Joint Replacement Registry is to monitor patients following joint replacement surgery that occurs at University Hospital Geelong and St John of God Hospital Geelong.

All patients undergoing joint replacement are routinely seen in pre-operative clinics as part of surgical planning. An Orthopaedic Coordinator will discuss the Registry with eligible patients and assist them, as required, to complete the relevant pre-operative assessment forms.

Post-operative follow-up procedures vary between Barwon Health and SJOG.

At Barwon Health, study participants will be assessed in-person at University Hospital Geelong (UHG) 3-6 months following the operation. Participants will then be assessed via mail-out at 1 year, 5 years and 8 years post-op and then biennially thereafter. Participants with complications or suspected complications identified via mail-out will be invited to the UHG for in-person review.

At SJOG, study participants will be assessed via mail-out at 12 months following the operation. Patients will also undergo clinical review with their surgeon at intervals decided by the surgeon, which is not considered part of the current study.
Trial website
Trial related presentations / publications
Public notes
The registry commenced as a quality improvement activity. At that stage, the project did not require formal ethics approval. Ethics approval was subsequently obtained as data were used for research purposes.

Contacts
Principal investigator
Name 88926 0
Prof Richard Page
Address 88926 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88926 0
Australia
Phone 88926 0
+61 3 5222 5777
Fax 88926 0
Email 88926 0
[email protected]
Contact person for public queries
Name 88927 0
Prof Richard Page
Address 88927 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88927 0
Australia
Phone 88927 0
+61 3 5222 5777
Fax 88927 0
Email 88927 0
[email protected]
Contact person for scientific queries
Name 88928 0
Dr Stephen Gill
Address 88928 0
Barwon Centre for Orthopaedic Research & Education (B-CORE)
St John of God Hospital Geelong
Myers St, Geelong, Victoria, Australia, 3220
Country 88928 0
Australia
Phone 88928 0
+61 3 52150902
Fax 88928 0
Email 88928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.