The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000317291
Ethics application status
Approved
Date submitted
7/02/2018
Date registered
2/03/2018
Date last updated
1/07/2019
Date data sharing statement initially provided
1/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective assessment of patient outcomes following joint replacement surgery
Scientific title
A prospective assessment of patient outcomes following joint replacement surgery performed by a single surgeon in private practice
Secondary ID [1] 293710 0
Nil known
Universal Trial Number (UTN)
U1111-1207-2027
Trial acronym
PAPOJRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Arthritis 306058 0
Hip Arthritis 306059 0
Condition category
Condition code
Musculoskeletal 305195 305195 0 0
Osteoarthritis
Musculoskeletal 305196 305196 0 0
Other muscular and skeletal disorders
Surgery 305715 305715 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Patients presenting with pathologies of the knee or hip and referred to specialist orthopaedic review and undergoing a Total Knee Replacement, Unicompartmental Knee Replacement or Total Hip Replacement.

1. Patients diagnosed with knee arthritis of any aetiology: Treated total knee arthroplasty or unicomparmental knee arthroplasty. Followed for a duration of 5 years.

2. Patients diagnosed with hip arthritis of any aetiology: Treated total hip arthroplasty. Followed for a duration of 5 years.
Intervention code [1] 299965 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304356 0
The incidence of patients that are deemed a "failure to cure" following definitive treatment, with failure to cure being considered if there is any of the following:
- Insufficient improvement in patient reported outcome measures (function or pain) when measured against minimally clinical important difference for the PROMs identified in secondary outcomes;
- Adverse findings on post-treatment medical imaging, as identified by radiologist and reported to the surgeon;
- Positive signs of instability, weakness or other primary pathology during clinical follow-up, measured by surgeon interpretation of ML stability and AP stability; or
- Failure to improve knee or hip range of motion, fixed flexion, extension lag and flexion contracture measured using a goniometer.
Timepoint [1] 304356 0
3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the specific pathology.
Secondary outcome [1] 341716 0
Rate of healing as determined using clinical imaging - radiographs (XR), computed tomography (CT), magnetic resonance imaging (MRI), and/or ultrasound (US), appropriate to the diagnosis
Timepoint [1] 341716 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [2] 341717 0
Joint range of motion assessed by goniometry
Timepoint [2] 341717 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [3] 341718 0
Complications and adverse events: any deviation from the ideal postoperative course that is not inherent in the procedure and does not comprise a failure to cure. E.g. surgical site infection as per the criteria described in Parvizi et al 2011 (CORR, 469). Assessed by surgeon interpretation and recorded via direct data entry into the research database. Secondary assessment via medical records and AOA reports if available.
Timepoint [3] 341718 0
intraoperatively, 2 weeks, 6weeks, 3months and 12 months following definitive treatment
Secondary outcome [4] 341719 0
Patient reported knee function assessed by Oxford Knee Score (OKS)
Timepoint [4] 341719 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [5] 341720 0
Patient reported hip function assessed by Oxford Hip Score (OHS)
Timepoint [5] 341720 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [6] 341721 0
Patient reported knee function and investigator reported range of motion and stability assessed by the Knee Society Score (KSS)
Timepoint [6] 341721 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [7] 341722 0
Patient reported hip function and investigator reported range of motion and stability assessed by the Harris Hip Score (HHS). Assessed via surgeon interpretation.
Timepoint [7] 341722 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.
Secondary outcome [8] 343798 0
Hardware positioning as determined using clinical imaging - radiographs (XR), computed tomography (CT), magnetic resonance imaging (MRI), and/or ultrasound (US), appropriate to the diagnosis
Timepoint [8] 343798 0
pre-treatment, 6weeks, 3months, 12months, 2years and 5years after clinical diagnosis within the specialist orthopaedic practice or following definitive treatment, depending on the diagnosis.

Eligibility
Key inclusion criteria
- Diagnosed with orthopaedic Hip or Knee pathology and booked for THR, TKR or UKR.
- Undergoing treatment by primary investigator/orthopaedic consultant surgeon.
- Consenting to being part of the Clinical Research Registry which is within the Sydney Bone and Joint Clinic
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient-reported outcomes: Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder).
- Revocation of consent for research use of personal data.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation; This clinical quality registry has been designed to capture >80% of patients presenting to the participating clinic as per the inclusion criteria to provide adequate internal validity of the results and generalisability to patients presenting to a private clinic in a major city of Australia.

The registry will routinely report data quality with respect to the core dataset. This will incorporate data completeness, consistency and validity. Registry primary and secondary outcomes will be reported annually.

Analyses relevant to each patient cohort will be pre-planned specific to the prospective questions identified for each.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9679 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 9680 0
Campbelltown Private Hospital - Campbelltown
Recruitment postcode(s) [1] 18445 0
2500 - Wollongong
Recruitment postcode(s) [2] 18446 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 298328 0
Self funded/Unfunded
Name [1] 298328 0
A/Prof John Ireland
Address [1] 298328 0
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue, Chipping Norton NSW, 2170
Country [1] 298328 0
Australia
Primary sponsor type
Individual
Name
A/Prof John Ireland
Address
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue, Chipping Norton NSW, 2170
Country
Australia
Secondary sponsor category [1] 297443 0
Commercial sector/Industry
Name [1] 297443 0
Exactech Inc.
Address [1] 297443 0
2320 NW 66th Court
GAINESVILLE FLORIDA 32653
USA
Country [1] 297443 0
United States of America
Other collaborator category [1] 279876 0
Commercial sector/Industry
Name [1] 279876 0
EBM Analytics
Address [1] 279876 0
27/8 Buller Road, Artarmon NSW 2064
Country [1] 279876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299320 0
Bellberry Ltd
Ethics committee address [1] 299320 0
129 Glen Osmond Road, Eastwood, SA 5063
Ethics committee country [1] 299320 0
Australia
Date submitted for ethics approval [1] 299320 0
18/08/2017
Approval date [1] 299320 0
03/01/2018
Ethics approval number [1] 299320 0
HREC2017-07-499

Summary
Brief summary
This is a prospective, observational cohort study assessing patient outcomes after joint replacement surgery. The purpose of this study is to assess clinical outcomes within the Investigator’s practice.
The primary objective of this protocol is the implementation of an ongoing registry to collate and store patient outcomes collected routinely as part of the standard clinical pathway for hip and knee arthroplasty at the Investigator’s practice. Outcomes will include objective joint function, pain, satisfaction, quality of life, radiology and revision surgery. The secondary objective is to integrate the clinical outcomes with analyses provided by the Australian National Joint Replacement Registry.
Recruitment will include all patients electing to undergo hip or knee arthroplasty surgery within the investigator's practice. Patients will undergo standard of care preoperative work-up, including the collection of demographic, medical history, radiology, pathology, and functional analysis. Patients will be required to complete the; EQ-5D 5L, and specific joint function outcomes will include Harris Hip Score (HHS), Oxford Hip Score (OHS), Oxford Knee Score (OKS), International Knee Society score (IKSS). Patient evaluation will be completed at the following time points: preoperatively and postoperatively at 2 to 6 weeks, 3 months, 12 months, 24 months and 5 years.
The clinical outcomes of individual patients will be monitored up to 5 years postoperatively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80042 0
A/Prof John Ireland
Address 80042 0
Sydney Bone and Joint Clinic
105-119 Longstaff Avenue, Chipping Norton NSW, 2170
Country 80042 0
Australia
Phone 80042 0
+612 9821 2596
Fax 80042 0
Email 80042 0
dr.ireland@sbjc.com.au
Contact person for public queries
Name 80043 0
Ms Claire Sinclair
Address 80043 0
Sydney Bone and Joint Clinic 105-119 Longstaff Avenue, Chipping Norton NSW, 2170
Country 80043 0
Australia
Phone 80043 0
+612 9821 2596
Fax 80043 0
Email 80043 0
claire.sinclair@sbjc.com.au
Contact person for scientific queries
Name 80044 0
Dr John Ireland
Address 80044 0
Sydney Bone and Joint Clinic 105-119 Longstaff Avenue, Chipping Norton NSW, 2170
Country 80044 0
Australia
Phone 80044 0
+612 9821 2596
Fax 80044 0
Email 80044 0
dr.ireland@sbjc.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is personal data and not legally allowed to be made public
What supporting documents are/will be available?
No other documents available
Summary results
No Results