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

The University of New South Wales

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Mobile bearing prosthesis; Device: Fixed bearing prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02157220

HC12098

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

77 participants in 2 patient groups

Randomised group 1

Experimental group

Description:

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:

Device: Fixed bearing prosthesis

Randomised group 2

Experimental group

Description:

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:

Device: Mobile bearing prosthesis