Trial Review

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
ACTRN12607000365460
Ethics application status
Approved
Date submitted
3/07/2007
Date registered
10/07/2007
Date last updated
15/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Journey Total Knee Athroplasty 'TKA' project: A comparison of two concepts for improved function of knee replacements.
Scientific title
Patients with osteoarthritis (OA) requiring TKR will have better functional outcomes and satisfaction with the Journey knee when compared to the Genesis II PS knee as measured by degrees of flexion and Oxford Knee Score at 2 years.
Secondary ID [1] 253575 0
Nil
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthrosis (OA) of the knee. 1943 0
Condition category
Condition code
Musculoskeletal 2040 2040 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a total knee replacement with either the Journey TKA. Implants will use Oxinium femurs and be fully cemented standard tibia baseplate. The prothesis is permanently implanted.
Intervention code [1] 1869 0
Treatment: Devices
Comparator / control treatment
Genesis II PS knee prothesis
Control group
Active

Outcomes
Primary outcome [1] 2865 0
Degrees of flexion – Objective outcome.
Timepoint [1] 2865 0
Assessed at Pre op, 6, 12, and 24 months. 6 minute walk test at 12 months.
Primary outcome [2] 2866 0
Oxford Knee Score – Subjective outcome.
Timepoint [2] 2866 0
Assessed at Pre op, 6, 12, and 24 months. 6 minute walk test at 12 months.
Secondary outcome [1] 4830 0
The migration pattern of the tibia trays.
Timepoint [1] 4830 0
Assessed at Pre op, 6, 12, 24 months
Secondary outcome [2] 4831 0
Rate of complications.
Timepoint [2] 4831 0
Assessed at Pre op, 6, 12, 24 months
Secondary outcome [3] 4832 0
Micro movements of polyethylene.
Timepoint [3] 4832 0
Assessed at Pre op, 6, 12, 24 months

Eligibility
Key inclusion criteria
Physically active patients, affected by OA of one knee and scheduled for primary TKA. Consent to study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflammatory or post trauma arthritis, Severe osteoporosis, steroid treatment, unclear reason for pain. Previous infection. Non compliance to study, 'Body Mass Index' >35, > 80 years, < 80° flexion, > 15° 'Fixed Flexion Deformity' or varus/ valgus deformity.

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



Intervention assignment
Parallel
Other design features
All investigators involved i.e. (the assessor and the data analyst) , except operating surgeon, blinded to choice of implant.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2006
Actual
6/11/2006
Date of last participant enrolment
Anticipated
2/11/2009
Actual
13/05/2010
Date of last data collection
Anticipated
1/06/2012
Actual
26/06/2012
Sample size
Target
240
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2182 0
Commercial sector/Industry
Name [1] 2182 0
Smith & Nephew, Inc
Country [1] 2182 0
Australia
Primary sponsor type
Other
Name
Perth Orthopaedic Institute
Address
Gate 3, Verdun St
NEDLANDS
WA 6009
Country
Australia
Secondary sponsor category [1] 1969 0
None
Name [1] 1969 0
N/A
Address [1] 1969 0
Country [1] 1969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3978 0
Pacific Private Clinic
Ethics committee address [1] 3978 0
Ethics committee country [1] 3978 0
Australia
Date submitted for ethics approval [1] 3978 0
Approval date [1] 3978 0
07/05/2007
Ethics approval number [1] 3978 0
200714
Ethics committee name [2] 3979 0
Perth Orthopaedic Institute
Ethics committee address [2] 3979 0
Ethics committee country [2] 3979 0
Australia
Date submitted for ethics approval [2] 3979 0
Approval date [2] 3979 0
07/10/2006
Ethics approval number [2] 3979 0
2006-076
Ethics committee name [3] 3980 0
Repatriation General Hospital
Ethics committee address [3] 3980 0
Ethics committee country [3] 3980 0
Australia
Date submitted for ethics approval [3] 3980 0
Approval date [3] 3980 0
01/11/2006
Ethics approval number [3] 3980 0
44/06

Summary
Brief summary
The specific aims are to compare Gen II and Journey TKA regarding :
•Patient satisfaction and functional outcome
•The degree of postoperative knee flexion.
•3D kinematics of the knee joints
•Gait pattern
•The rate of complications and difficulties
•The migration pattern of the tibia trays
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27683 0
Professor Bo Nivbrant
Address 27683 0
Perth Orthopaedic Institute
Gate 3, Verdun St
Nedlands WA 6009
Country 27683 0
Australia
Phone 27683 0
+61 8 93866211
Fax 27683 0
Email 27683 0
[email protected]
Contact person for public queries
Name 11058 0
Mr Mausam Doctor
Address 11058 0
85 Waterloo Road, North Ryde, NSW - 2113
Country 11058 0
Australia
Phone 11058 0
+61 2 98573999
Fax 11058 0
+61 2 98573900
Email 11058 0
[email protected]
Contact person for scientific queries
Name 1986 0
Prof Professor Bo Nivbrant
Address 1986 0
Perth Orthopaedic Institute
Gate 3
Verdun St
Nedlands WA 6009
Country 1986 0
Australia
Phone 1986 0
+61 8 93866211
Fax 1986 0
Email 1986 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseTotal Knee Arthroplasty Using Bicruciate-Stabilized or Posterior-Stabilized Knee Implants Provided Comparable Outcomes at 2 Years: A Prospective, Multicenter, Randomized, Controlled, Clinical Trial of Patient Outcomes.2017https://dx.doi.org/10.1016/j.arth.2017.05.032
N.B. These documents automatically identified may not have been verified by the study sponsor.