Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001465145
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
23/10/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
23/10/2019
Date results information initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Failure of Unicompartmental knee replacement bearings
Scientific title
Catastrophic Failure of Convex Unicompartmental Polyethylene bearings
Secondary ID [1] 299320 0
nil known
Universal Trial Number (UTN)
U1111-1240-2986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 314455 0
arthroplasty 314456 0
Condition category
Condition code
Musculoskeletal 312790 312790 0 0
Osteoarthritis
Surgery 312928 312928 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
Observational study of patients in an institutional data base that have had a unicompartmental knee arthroplasty including a convex polyethylene bearing to ten years.

Patients complete PROMS (see section 4) as routine care at pre op, 6 weeks, 6 month, 12, 24, 60 and 120 months. Radiology at pre op, immediately post op, 12, 24, 60 and 120 months post op.
Intervention code [1] 315584 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321411 0
knee society scores
Timepoint [1] 321411 0
pre op, 1,2 5, 10 years
Primary outcome [2] 321658 0
visual analogue score of satisfaction
Timepoint [2] 321658 0
pre op, 1,2 5, 10 years
Primary outcome [3] 321659 0
range of motion assessed with goniometer
Timepoint [3] 321659 0
pre op, 1,2 5, 10 years
Secondary outcome [1] 374898 0
revision knee surgery, self reported data
Timepoint [1] 374898 0
assessed at incidence from 0 to 10 years post-operative
Secondary outcome [2] 376013 0
visual analogue score of pain
Timepoint [2] 376013 0
pre op, 1,2 5, 10 years

Eligibility
Key inclusion criteria
All patients having a BalanSys unicompartmental knee arthroplasty including a convex polyethylene bearing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
descriptive demographics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2019
Actual
23/10/2019
Date of last participant enrolment
Anticipated
23/10/2019
Actual
23/10/2019
Date of last data collection
Anticipated
23/10/2019
Actual
23/10/2019
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14807 0
Calvary Wakefield Hospital - Adelaide
Recruitment postcode(s) [1] 28056 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303837 0
Self funded/Unfunded
Name [1] 303837 0
Country [1] 303837 0
Primary sponsor type
Individual
Name
David Campbell
Address
Wakefield Orthopaedic Clinic
270 Wakefield Street, Adelaide,
South Australia 5000
Country
Australia
Secondary sponsor category [1] 303968 0
None
Name [1] 303968 0
Address [1] 303968 0
Country [1] 303968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304352 0
Calvary Health Care Adelaide Human Research Ethics Committee
Ethics committee address [1] 304352 0
CHCA Human Research Ethics Committee
Calvary SA Office
c/o Calvary Wakefield Hospital
300 Wakefield Street
Adelaide 5000
Ethics committee country [1] 304352 0
Australia
Date submitted for ethics approval [1] 304352 0
10/09/2019
Approval date [1] 304352 0
04/10/2019
Ethics approval number [1] 304352 0
19-CHREC-E006

Summary
Brief summary
This trial reports the unforeseen consequence of a novel design of a unicompartmental knee arthroplasty (UKA) that resulted in a specific mechanical and tribiological mode of failure.

Convex polyethylene bearings were developed to decrease bearing dislocation and used in 32 patients with disabling medial compartment osteoarthritis of the knee.

This study reports the clinical outcomes (PROMS) and revisions for failed implants,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96650 0
A/Prof David Campbell
Address 96650 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia 5000
Country 96650 0
Australia
Phone 96650 0
+61 8 82364196
Fax 96650 0
Email 96650 0
[email protected]
Contact person for public queries
Name 96651 0
A/Prof David Campbell
Address 96651 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia 5000
Country 96651 0
Australia
Phone 96651 0
+61 8 82364196
Fax 96651 0
Email 96651 0
[email protected]
Contact person for scientific queries
Name 96652 0
A/Prof David Campbell
Address 96652 0
Wakefield Orthopaedic Clinic
270 Wakefield Street
Adelaide
South Australia 5000
Country 96652 0
Australia
Phone 96652 0
+61 8 82364196
Fax 96652 0
Email 96652 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Catastrophic failure of biconcave unicompartmental... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCatastrophic failure of biconcave unicompartmental polyethylene bearings.2020https://dx.doi.org/10.1016/j.knee.2020.02.005
N.B. These documents automatically identified may not have been verified by the study sponsor.