Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157220
• Other study ID #: HC12098
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: June 3, 2014
• Start date: May 2005
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: National Health and Medical Research Council, Australia:
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty

Exclusion Criteria:

• refusal to participate

• other simultaneous surgery

• post traumatic osteoarthritis

• prior open knee surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Fixed bearing prosthesis

• Mobile bearing prosthesis

Locations

Country	Name	City	State
Australia	Dr Dean Pepper, orthopaedic surgeon private rooms	Port Macquarie	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual pain analogue score	Participants asked to rate their level of pain on a scale	6 weeks
Primary	Range of motion	The range of motion of the joint was assessed in both flexion and extension	6 weeks
Primary	Activities of Daily Living	Questionnaire looking at how the intervention impacts of activities of daily living	6 weeks
Primary	X-ray analysis of joint alignment	Using X-rays, the knee was assessed for mechanical and anatomical alignment	5-7 year
Primary	Visual pain analogue score		6 months
Primary	visual pain analogue score		12 months
Primary	visual analogue pain score		5-7 years
Primary	range of motion		6 months
Primary	range of motion		1 year
Primary	range of motion		5-7 years
Primary	activities of daily living		6 months
Primary	activities of daily living		1 year
Primary	activities of daily living		5-7 years