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Trial registered on ANZCTR
Registration number
ACTRN12620000183987
Ethics application status
Approved
Date submitted
17/01/2020
Date registered
18/02/2020
Date last updated
21/01/2024
Date data sharing statement initially provided
18/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective Registry of Knee Pathology in private practice
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Scientific title
Prospective Registry of Knee Pathology: A clinical quality registry of patients treated in private practice
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Secondary ID [1]
300297
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None
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Universal Trial Number (UTN)
U1111-1246-8616
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Trial acronym
PRoKPath
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Instability
315888
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Knee Arthritis
315889
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Knee pathology, not otherwise specified
315890
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ACL pathology/rupture
315891
0
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Condition category
Condition code
Musculoskeletal
314164
314164
0
0
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Osteoarthritis
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Musculoskeletal
314165
314165
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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Description of intervention(s) / exposure
1. Patients presenting with episodes of giving way (with or without primary anterior cruciate ligament rupture), managed with arthroscopic ligament reconstruction. Outcomes monitored up to 2 years via patient-completed questionnaires and medical record review.
2. Patients presenting with degenerative knee conditions (OA, RA) failing non-operative management, managed with total knee arthroplasty. Outcomes monitored up to 2 years via patient-completed questionnaires and medical record review.
3. Patients presenting with knee osteoarthritis affecting predominantly the medial or lateral compartment (with or without patellofemoral joint involvement), eligible and electing to undergo realignment osteotomy. Managed with opening-wedge high tibial osteotomy, or closing wedge distal femoral osteotomy. Outcomes monitored up to 2 years via patient-completed questionnaires and medical record review.
4. Patients presenting with complaints regarding a previously implanted total knee replacement; reviewed by a consultant orthopaedic surgeon and offered surgical or non-surgical treatment. Outcomes monitored up to 2 years via patient-completed questionnaires and medical record review.
5. Patients presenting with knee conditions not eligible for inclusion in other cohorts. Managed operatively or nonoperatively. Outcomes monitored up to 2 years via patient-completed questionnaires and medical record review.
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Intervention code [1]
316572
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
322549
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The incidence of patients deemed a "failure to cure" following definitive treatment. Composite outcome consisting of insufficient improvement in patient reported outcome measures (function or pain; IKDC, SANE, KOOS/KOOS-12/KOOS-JR, ACL-RSI, MODEMS, Marx activity as relevant to pathology, movement restrictions as measured by goniometry); adverse findings on post-treatment medical imaging (eg. implant loosening); positive signs of instability, weakness or other primary pathology during clinical follow-up
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Assessment method [1]
322549
0
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Timepoint [1]
322549
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12months following definitive treatment (non-operative OR surgical), depending on the specific pathology.
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Secondary outcome [1]
378908
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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 Frangiamore et al 2015, intraoperative implant breakage, etc. This data will be obtained through medical records, and may be reported by participants during follow-up appointments with the specialist.
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Assessment method [1]
378908
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Timepoint [1]
378908
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intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)
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Secondary outcome [2]
378909
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Joint range of motion assessed by goniometry
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Assessment method [2]
378909
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Timepoint [2]
378909
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pre-treatment (initial consultation), 3months, 6months, 12months following definitive treatment (non-operative OR surgical), depending on the specific pathology.
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Secondary outcome [3]
378910
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MODEMs Expectation Scale
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Assessment method [3]
378910
0
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Timepoint [3]
378910
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pre-treatment (initial consultation), 6 months, 12 months following definitive treatment.
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Secondary outcome [4]
378911
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International Knee Documentation Committee (IKDC) Subjective evaluation scale [Instability cohort only]
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Assessment method [4]
378911
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Timepoint [4]
378911
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pre-treatment (initial consultation), 3 months, 6 months, 12 months, 24 months following definitive treatment
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Secondary outcome [5]
378912
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Marx activity scale
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Assessment method [5]
378912
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Timepoint [5]
378912
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Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
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Secondary outcome [6]
378913
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ACL return to sport index (ACL-RSI) [Instability cohort only]
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Assessment method [6]
378913
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Timepoint [6]
378913
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Pre-treatment (initial consultation), 6 months, 12 months following definitive treatment
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Secondary outcome [7]
378914
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Veteran's Rand-12 General wellbeing scale
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Assessment method [7]
378914
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Timepoint [7]
378914
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Pre-treatment (initial consultation) only
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Secondary outcome [8]
378915
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Single assessment numeric evaluation (SANE) global score
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Assessment method [8]
378915
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Timepoint [8]
378915
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Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
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Secondary outcome [9]
378916
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Knee Osteoarthritis Outcome Score (KOOS)
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Assessment method [9]
378916
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Timepoint [9]
378916
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Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
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Secondary outcome [10]
378917
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Willingness to have procedure again (assessed as a single questionnaire item)
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Assessment method [10]
378917
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Timepoint [10]
378917
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12 and 24 months following surgical treatment
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Secondary outcome [11]
378918
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KOOS JR Joint-replacement-specific score [Arthritis and Osteotomy cohorts only]
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Assessment method [11]
378918
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Timepoint [11]
378918
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Pre-treatment (initial consultation), 6 months, 12 months, 24 months following knee replacement
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Secondary outcome [12]
404489
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KOOS-12 item knee function score [Re-intervention knee arthroplasty cohort only]
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Assessment method [12]
404489
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Timepoint [12]
404489
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at baseline, and 6, 12 and 24 months after definitive treatment.
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Eligibility
Key inclusion criteria
Knee conditions eligible for one of the prespecified cohorts: Knee Instability, Knee Arthritis (eligible for total knee replacement), Knee Osteotomy, or other primary pathologies (ie. Knee General).
Undergoing treatment by the consulting surgeon at Melbourne Orthopaedic Group.
Received information package associated with opt-out consent process.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Sample size calculations were based upon a rule of thumb of 10 treatment failure events per variable entered into a binary logistic regression model, assuming clinical failure rates for specific procedures taken from similar cohorts reported in the literature. Final target sample sizes for each cohort were calculated to have 80% power to detect a significant effect for 5 predictor variables, allowing for up to 10% protocol non-compliance and a 2-sided alpha of 0.05.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
6/04/2020
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Actual
1/06/2020
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Date of last participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last data collection
Anticipated
4/06/2027
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Actual
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Sample size
Target
2500
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Accrual to date
2657
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
29035
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3000 - Melbourne
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Recruitment postcode(s) [2]
29033
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3122 - Hawthorn
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Recruitment postcode(s) [3]
29034
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3181 - Windsor
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Funding & Sponsors
Funding source category [1]
304707
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Charities/Societies/Foundations
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Name [1]
304707
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Melbourne Orthopaedic Research Institute Ltd
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Address [1]
304707
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Melbourne Orthopaedic Research Institute; 33 The Avenue, Melbourne, 3181, Victoria
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Country [1]
304707
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Australia
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Primary sponsor type
Individual
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Name
Timothy Lording
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Address
Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
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Country
Australia
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Secondary sponsor category [1]
305035
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None
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Name [1]
305035
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Address [1]
305035
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Country [1]
305035
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Other collaborator category [1]
281140
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Individual
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Name [1]
281140
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Corey Scholes
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Address [1]
281140
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EBM Analytics, 119 Willoughby Road, Crows Nest, 2065, New South Wales
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Country [1]
281140
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305134
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Bellberry Ltd
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Ethics committee address [1]
305134
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123 Glen Osmond Road, Eastwood, 5063, South Australia
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Ethics committee country [1]
305134
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Australia
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Date submitted for ethics approval [1]
305134
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24/01/2020
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Approval date [1]
305134
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11/05/2020
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Ethics approval number [1]
305134
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2020-01-048
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Summary
Brief summary
The primary purpose of this study is to analyse and report on outcomes following treatment for patients presenting to a single orthopaedic surgeon, Mr Timothy Lording, for management of conditions affecting the knee. This clinical registry will collate and store patient outcomes collected routinely as part of the standard clinical pathway for knee treatments. Outcomes will include objective joint function, patient reported outcomes (pain, satisfaction, quality of life), radiological findings and rates of revision surgery or complications. The main hypothesis arising from the registry is that specific factors present before treatment will predict the likelihood of a patient experiencing a positive, or negative outcome (whether clinically indicated or patient-reported) following surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
99358
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A/Prof Timothy Lording
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Address
99358
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Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
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Country
99358
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Australia
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Phone
99358
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+61395739694
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Fax
99358
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Email
99358
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Timothy.Lording@monash.edu
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Contact person for public queries
Name
99359
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Timothy Lording
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Address
99359
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Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
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Country
99359
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Australia
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Phone
99359
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+61395739694
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Fax
99359
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Email
99359
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Timothy.Lording@monash.edu
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Contact person for scientific queries
Name
99360
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Corey Scholes
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Address
99360
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EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
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Country
99360
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Australia
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Phone
99360
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+61299563800
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Fax
99360
0
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Email
99360
0
cscholes@ebma.com.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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