Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000138987p
Ethics application status
Submitted, not yet approved
Date submitted
22/01/2020
Date registered
12/02/2020
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Stability of the Score Mobile Bearing Total Knee Replacement
Scientific title
Stability of the Uncemented Tibial component of the Score Mobile Bearing Total Knee Arthroplasty
Secondary ID [1] 300346 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis
 315959 0
Condition category
Condition code
Musculoskeletal 314227 314227 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive an uncemented tibial component Score Mobile bearing Total Knee Arthroplasty. The operation takes 45-60 minutes and is performed in the standard fashion, excepting the implantation of RSA beads around the implant. The operation date and limb side will be recorded from the surgeons private database. No other theatre details have relevance in this commonly performed surgery. Followup assessment postoperatively, at 3 months, 1 and 2 years will radiographically assess implant migration.
Intervention code [1] 316624 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322620 0
Implant migration (Radiostereometric analysis)
Timepoint [1] 322620 0
0, 3 months, 1 and 2 years (primary timepoint) post-surgical treatment
Secondary outcome [1] 379049 0
Patient reported outcome pain (numeral rating 0-10)
Timepoint [1] 379049 0
0, 3 months, 1 and 2 years (primary timepoint) post-surgical treatment
Secondary outcome [2] 379051 0
Patient reported outcome function (Oxford knee score 0-48 forgotten knee score)
Timepoint [2] 379051 0
0, 3 months, 1 and 2 years (primary timepoint) post-surgical treatment

Eligibility
Key inclusion criteria
1. consenting male and female patients
2. aged 50 to 75-years
3. degenerative native knee-joint pathology
4. adequate bone stock for uncemented tibial fixation
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. local knee joint infection or significant systemic disease
2. affected by neuromuscular or sensory pathology
3. immunosuppressed
4. morbidly obese (BMI equal to or higher than 40)
5. unable to comply with the postoperative follow-up investigations to be inducted into the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A significance level of 0.05 and power of 0.8 will be used to determine change of outcome by time.
Frequency and percentage distributions will be presented in tabular form for categorical variables and the chi-square test for 2-way contingency tables will be used for comparison of the study groups. The mean, median, standard deviation, minimum and maximum will be presented by study group for quantitative variables and the appropriate parametric or non-parametric statistical test will be used, depending on the distribution of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
2/09/2020
Actual
Date of last data collection
Anticipated
2/09/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15674 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 29091 0
6009 - Nedlands
Recruitment postcode(s) [2] 29092 0
6009 - Broadway Nedlands

Funding & Sponsors
Funding source category [1] 304772 0
Commercial sector/Industry
Name [1] 304772 0
Amplitude (TBC)
Country [1] 304772 0
Australia
Primary sponsor type
Other
Name
The Joint Studio
Address
Suite 1/85 Monash Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 305086 0
None
Name [1] 305086 0
Address [1] 305086 0
Country [1] 305086 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305187 0
Ramsay Hospital HREC
Ethics committee address [1] 305187 0
Hollywood Hospital, Monash Ave, Nedlands WA 6009
Ethics committee country [1] 305187 0
Australia
Date submitted for ethics approval [1] 305187 0
17/01/2020
Approval date [1] 305187 0
Ethics approval number [1] 305187 0

Summary
Brief summary
SCORE® is a primary total knee arthroplasty implant designed to achieve stability through congruency, has a rotating platform and a mobile bearing surface. Unlike cemented fixed-bearing implants, more congruent rotating platforms aim to reduce contact stress peaks and polyethylene wear, also to reduce contact strain peaks at the bone-implant interface to reduce the risk of loosening.The design of the femoral trochlea has also become more anatomical to improve patellar stability and reduce the number of patellofemoral complications.

SCORE®TKA (Amplitude, Valence, France) uses traditional instrumentation and computer navigation (Amplivision®) to control bone cuts, mechanical alignment and ligament balance. Very satisfying results for the Score implant have been reported in the literature however there we were unable to locate any published results affirming the stability this implant affords using high quality measurements, as that of RSA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99538 0
Prof Riaz Khan
Address 99538 0
The Joint Studio, Suite 1/85 Monash Ave, Nedlands WA 6009
Country 99538 0
Australia
Phone 99538 0
+61 8 9386 3933
Fax 99538 0
Email 99538 0
[email protected]
Contact person for public queries
Name 99539 0
Ms Samantha Haebich
Address 99539 0
The Joint Studio, Suite 1/85 Monash Ave, Nedlands WA 6009
Country 99539 0
Australia
Phone 99539 0
+61 8 9386 3933
Fax 99539 0
Email 99539 0
[email protected]
Contact person for scientific queries
Name 99540 0
Prof Riaz Khan
Address 99540 0
The Joint Studio, Suite 1/85 Monash Ave, Nedlands WA 6009
Country 99540 0
Australia
Phone 99540 0
+61 8 9386 3933
Fax 99540 0
Email 99540 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
Minimal administrative support


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.