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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Fixed bearing prosthesis; Device: Mobile bearing prosthesis

• Registration Number: NCT02157220
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2012-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-30
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Study First Posted: 2014-06-05
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

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

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Exclusion Criteria

• refusal to participate
• other simultaneous surgery
• post traumatic osteoarthritis
• prior open knee surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomised group 1	Fixed bearing prosthesis	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.
Randomised group 2	Mobile bearing prosthesis	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.

Primary Outcome Measures

Name	Time	Method
Visual pain analogue score	6 months
X-ray analysis of joint alignment	5-7 year	Using X-rays, the knee was assessed for mechanical and anatomical alignment
range of motion	5-7 years
visual analogue pain score	5-7 years
activities of daily living	5-7 years
Activities of Daily Living	6 weeks	Questionnaire looking at how the intervention impacts of activities of daily living
visual pain analogue score	12 months
Range of motion	6 weeks	The range of motion of the joint was assessed in both flexion and extension

Trial Locations

Locations (1)

Dr Dean Pepper, orthopaedic surgeon private rooms; 🇦🇺 Port Macquarie, New South Wales, Australia