OsteoarthritisNCT02157220
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
A study testing Fixed bearing prosthesis and Mobile bearing prosthesis in people with Osteoarthritis, run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fixed bearing prosthesis and Mobile bearing prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteAustralia
- Study dates
- May 2005to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty
Who cannot join
- refusal to participate
- other simultaneous surgery
- post traumatic osteoarthritis
- prior open knee surgery
Trial locations and contacts
1 site in 1 country.
Australia1 site
Dr Dean Pepper, orthopaedic surgeon private rooms
Port Macquarie, New South Wales, 2444
About this study
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.
- Conditions
- Osteoarthritis
- Being tested
- Fixed bearing prosthesis, Mobile bearing prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed bearing prosthesisDevice
Mobile bearing prosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| Randomised group 1 | Experimental | 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. Receives: Device: Fixed bearing prosthesis |
| Randomised group 2 | Experimental | 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. Receives: Device: Mobile bearing prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual pain analogue score
Participants asked to rate their level of pain on a scale
Measured: 6 weeks
Range of motion
The range of motion of the joint was assessed in both flexion and extension
Measured: 6 weeks
Activities of Daily Living
Questionnaire looking at how the intervention impacts of activities of daily living
Measured: 6 weeks
X-ray analysis of joint alignment
Using X-rays, the knee was assessed for mechanical and anatomical alignment
Measured: 5-7 year
Visual pain analogue score
Measured: 6 months
visual pain analogue score
Measured: 12 months
visual analogue pain score
Measured: 5-7 years
range of motion
Measured: 6 months
range of motion
Measured: 1 year
range of motion
Measured: 5-7 years
activities of daily living
Measured: 6 months
activities of daily living
Measured: 1 year
activities of daily living
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2005
- Primary completionMay 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Handford, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157220
- Sponsor's protocol ID
- HC12098
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
- ClinicalTrials.gov ID
- NCT02157220
- Acronym / sponsor ID
- HC12098
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomised group 1 | Experimental | Device: Fixed bearing prosthesisThis 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. |
| Randomised group 2 | Experimental | Device: Mobile bearing prosthesisThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty
Key exclusion criteria (4 listed)
- refusal to participate
- other simultaneous surgery
- post traumatic osteoarthritis
- prior open knee surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed bearing prosthesis | Device | Randomised group 1 |
| Mobile bearing prosthesis | Device | Randomised group 2 |
Primary outcome
Visual pain analogue score
Time frame: 6 weeks
Participants asked to rate their level of pain on a scale
Range of motion
Time frame: 6 weeks
The range of motion of the joint was assessed in both flexion and extension
Activities of Daily Living
Time frame: 6 weeks
Questionnaire looking at how the intervention impacts of activities of daily living
X-ray analysis of joint alignment
Time frame: 5-7 year
Using X-rays, the knee was assessed for mechanical and anatomical alignment
Visual pain analogue score
Time frame: 6 months
visual pain analogue score
Time frame: 12 months
visual analogue pain score
Time frame: 5-7 years
range of motion
Time frame: 6 months
range of motion
Time frame: 1 year
range of motion
Time frame: 5-7 years
activities of daily living
Time frame: 6 months
activities of daily living
Time frame: 1 year
activities of daily living
Time frame: 5-7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed bearing prosthesis and Mobile bearing prosthesis in people with Osteoarthritis, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual pain analogue score (time frame: 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.