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

NCT02157220 | Completed

• 1 other identifier: HC12098
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (13)

• Visual pain analogue score

  Participants asked to rate their level of pain on a scale

  6 weeks

• Range of motion

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

  6 weeks

• Activities of Daily Living

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

  6 weeks

• X-ray analysis of joint alignment

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

  5-7 year

• Visual pain analogue score

  6 months

• visual pain analogue score

  12 months

• visual analogue pain score

  5-7 years

• range of motion

  6 months

• range of motion

  1 year

• range of motion

  5-7 years

• activities of daily living

  6 months

• activities of daily living

  1 year

• activities of daily living

  5-7 years

Study Arms (2)

Randomised group 1

EXPERIMENTAL

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.

Device: Fixed bearing prosthesis

Randomised group 2

EXPERIMENTAL

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.

Device: Mobile bearing prosthesis

Interventions

Fixed bearing prosthesis DEVICE

Randomised group 1

Mobile bearing prosthesis DEVICE

Randomised group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

Dr Dean Pepper, orthopaedic surgeon private rooms

Port Macquarie, New South Wales, 2444, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Cameron Handford

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2005
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2014
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

AU (1)