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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02157220




Registration number
NCT02157220
Ethics application status
Date submitted
30/05/2014
Date registered
5/06/2014
Date last updated
5/06/2014

Titles & IDs
Public title
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
Scientific title
Secondary ID [1] 0 0
HC12098
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Fixed bearing prosthesis
Treatment: Devices - Mobile bearing prosthesis

Experimental: Randomised group 1 - This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.

Experimental: Randomised group 2 - This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.


Treatment: Devices: Fixed bearing prosthesis


Treatment: Devices: Mobile bearing prosthesis


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual pain analogue score - Participants asked to rate their level of pain on a scale
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Range of motion - The range of motion of the joint was assessed in both flexion and extension
Timepoint [2] 0 0
6 weeks
Primary outcome [3] 0 0
Activities of Daily Living - Questionnaire looking at how the intervention impacts of activities of daily living
Timepoint [3] 0 0
6 weeks
Primary outcome [4] 0 0
X-ray analysis of joint alignment - Using X-rays, the knee was assessed for mechanical and anatomical alignment
Timepoint [4] 0 0
5-7 year
Primary outcome [5] 0 0
Visual pain analogue score
Timepoint [5] 0 0
6 months
Primary outcome [6] 0 0
visual pain analogue score
Timepoint [6] 0 0
12 months
Primary outcome [7] 0 0
visual analogue pain score
Timepoint [7] 0 0
5-7 years
Primary outcome [8] 0 0
range of motion
Timepoint [8] 0 0
6 months
Primary outcome [9] 0 0
range of motion
Timepoint [9] 0 0
1 year
Primary outcome [10] 0 0
range of motion
Timepoint [10] 0 0
5-7 years
Primary outcome [11] 0 0
activities of daily living
Timepoint [11] 0 0
6 months
Primary outcome [12] 0 0
activities of daily living
Timepoint [12] 0 0
1 year
Primary outcome [13] 0 0
activities of daily living
Timepoint [13] 0 0
5-7 years

Eligibility
Key inclusion criteria
- patients presenting to a single orthopaedic surgeon with knee pathology, who were
suitable candidates for total knee arthroplasty
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- refusal to participate

- other simultaneous surgery

- post traumatic osteoarthritis

- prior open knee surgery

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW
Recruitment hospital [1] 0 0
Dr Dean Pepper, orthopaedic surgeon private rooms - Port Macquarie
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomised control trial comparing two different prosthetic designs used in total
knee arthroplasty. Participants were randomised to receive either of the two prostheses and
then were followed up of a period of 7 years, looking at pain, range of motion and impact on
quality of life. The literature and joint registry of Australia shows that one of the
prosthesis may be inferior to the other. Our research team hypothesised that this was not the
case and that previous elicited differences were related to other factors.
Trial website
https://clinicaltrials.gov/show/NCT02157220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications