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

NCT ID: NCT02157220

Last Updated: 2014-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Fixed bearing prosthesis

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Mobile bearing prosthesis

Intervention Type DEVICE

Interventions

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Fixed bearing prosthesis

Intervention Type DEVICE

Mobile bearing prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Cameron Handford

Dr Cameron Handford

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr Dean Pepper, orthopaedic surgeon private rooms

Port Macquarie, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HC12098

Identifier Type: -

Identifier Source: org_study_id

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