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OpenTrials
Completed

NCT Number: NCT02157220

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Dean Pepper, orthopaedic surgeon private rooms

Port Macquarie, New South Wales, 2444, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed bearing prosthesis

Device

Mobile bearing prosthesis

Device

Primary outcomes

  1. Visual pain analogue score

    Time frame: 6 weeks

    Participants asked to rate their level of pain on a scale

  2. Range of motion

    Time frame: 6 weeks

    The range of motion of the joint was assessed in both flexion and extension

  3. Activities of Daily Living

    Time frame: 6 weeks

    Questionnaire looking at how the intervention impacts of activities of daily living

  4. X-ray analysis of joint alignment

    Time frame: 5-7 year

    Using X-rays, the knee was assessed for mechanical and anatomical alignment

  5. Visual pain analogue score

    Time frame: 6 months

  6. visual pain analogue score

    Time frame: 12 months

  7. visual analogue pain score

    Time frame: 5-7 years

  8. range of motion

    Time frame: 6 months

  9. range of motion

    Time frame: 1 year

  10. range of motion

    Time frame: 5-7 years

  11. activities of daily living

    Time frame: 6 months

  12. activities of daily living

    Time frame: 1 year

  13. activities of daily living

    Time frame: 5-7 years

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2014
First posted
Jun 5, 2014
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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