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Trial registered on ANZCTR


Registration number
ACTRN12620000183987p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2020
Date registered
18/02/2020
Date last updated
3/03/2020
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
Scientific title
Prospective Registry of Knee Pathology: A clinical quality registry of patients treated in private practice
Secondary ID [1] 300297 0
None
Universal Trial Number (UTN)
U1111-1246-8616
Trial acronym
PRoKPath
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Instability 315888 0
Knee Arthritis 315889 0
Knee pathology, not otherwise specified 315890 0
ACL pathology/rupture 315891 0
Condition category
Condition code
Musculoskeletal 314164 314164 0 0
Osteoarthritis
Musculoskeletal 314165 314165 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
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 eligible and electing to undergo 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 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.
Intervention code [1] 316572 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322549 0
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-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
Timepoint [1] 322549 0
12months following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [1] 378908 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 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.
Timepoint [1] 378908 0
intraoperatively, 2 weeks, 6weeks, 3months following definitive treatment (non-operative OR surgical)
Secondary outcome [2] 378909 0
Joint range of motion assessed by goniometry
Timepoint [2] 378909 0
pre-treatment (initial consultation), 3months, 6months, 12months following definitive treatment (non-operative OR surgical), depending on the specific pathology.
Secondary outcome [3] 378910 0
MODEMs Expectation Scale
Timepoint [3] 378910 0
pre-treatment (initial consultation), 6 months, 12 months following definitive treatment.
Secondary outcome [4] 378911 0
International Knee Documentation Committee (IKDC) Subjective evaluation scale [Instability cohort only]
Timepoint [4] 378911 0
pre-treatment (initial consultation), 3 months, 6 months, 12 months, 24 months following definitive treatment
Secondary outcome [5] 378912 0
Marx activity scale
Timepoint [5] 378912 0
Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
Secondary outcome [6] 378913 0
ACL return to sport index (ACL-RSI) [Instability cohort only]
Timepoint [6] 378913 0
Pre-treatment (initial consultation), 6 months, 12 months following definitive treatment
Secondary outcome [7] 378914 0
Veteran's Rand-12 General wellbeing scale
Timepoint [7] 378914 0
Pre-treatment (initial consultation) only
Secondary outcome [8] 378915 0
Single assessment numeric evaluation (SANE) global score
Timepoint [8] 378915 0
Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
Secondary outcome [9] 378916 0
Knee Osteoarthritis Outcome Score (KOOS)
Timepoint [9] 378916 0
Pre-treatment (initial consultation), 6 months, 12 months, 24 months following definitive treatment
Secondary outcome [10] 378917 0
Willingness to have procedure again (assessed as a single questionnaire item)
Timepoint [10] 378917 0
12 and 24 months following surgical treatment
Secondary outcome [11] 378918 0
KOOS JR Joint-replacement-specific score [Arthritis and Osteotomy cohorts only]
Timepoint [11] 378918 0
Pre-treatment (initial consultation), 6 months, 12 months, 24 months following knee replacement

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.
Minimum age
14 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment postcode(s) [1] 29035 0
3000 - Melbourne
Recruitment postcode(s) [2] 29033 0
3122 - Hawthorn
Recruitment postcode(s) [3] 29034 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 304707 0
Charities/Societies/Foundations
Name [1] 304707 0
Melbourne Orthopaedic Research Institute Ltd
Address [1] 304707 0
Melbourne Orthopaedic Research Institute; 33 The Avenue, Melbourne, 3181, Victoria
Country [1] 304707 0
Australia
Primary sponsor type
Individual
Name
Timothy Lording
Address
Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
Country
Australia
Secondary sponsor category [1] 305035 0
None
Name [1] 305035 0
Address [1] 305035 0
Country [1] 305035 0
Other collaborator category [1] 281140 0
Individual
Name [1] 281140 0
Corey Scholes
Address [1] 281140 0
EBM Analytics, 119 Willoughby Road, Crows Nest, 2065, New South Wales
Country [1] 281140 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305134 0
Bellberry Ltd
Ethics committee address [1] 305134 0
123 Glen Osmond Road, Eastwood, 5063, South Australia
Ethics committee country [1] 305134 0
Australia
Date submitted for ethics approval [1] 305134 0
24/01/2020
Approval date [1] 305134 0
Ethics approval number [1] 305134 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99358 0
A/Prof Timothy Lording
Address 99358 0
Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
Country 99358 0
Australia
Phone 99358 0
+61395739694
Fax 99358 0
Email 99358 0
Timothy.Lording@monash.edu
Contact person for public queries
Name 99359 0
A/Prof Timothy Lording
Address 99359 0
Melbourne Orthopaedic Group; 33 The Avenue, Melbourne, 3181, Victoria
Country 99359 0
Australia
Phone 99359 0
+61395739694
Fax 99359 0
Email 99359 0
Timothy.Lording@monash.edu
Contact person for scientific queries
Name 99360 0
Dr Corey Scholes
Address 99360 0
EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
Country 99360 0
Australia
Phone 99360 0
+61299563800
Fax 99360 0
Email 99360 0
cscholes@ebma.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
What supporting documents are/will be available?
No other documents available
Summary results
No Results