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

• Sponsor: The University of New South Wales (Other)
• Overall Status: Completed
• CT.gov ID: NCT02157220
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Duration (Months): 108
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: Fixed bearing prosthesis; Device: Mobile bearing prosthesis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Fixed bearing prosthesis
Experimental: 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.	Device: Mobile bearing prosthesis

Outcome Measures

Primary Outcome Measures

1. Visual pain analogue score [6 weeks]

   Participants asked to rate their level of pain on a scale

2. Range of motion [6 weeks]

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

3. Activities of Daily Living [6 weeks]

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

4. X-ray analysis of joint alignment [5-7 year]

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

5. Visual pain analogue score [6 months]

6. visual pain analogue score [12 months]

7. visual analogue pain score [5-7 years]

8. range of motion [6 months]

9. range of motion [1 year]

10. range of motion [5-7 years]

11. activities of daily living [6 months]

12. activities of daily living [1 year]

13. activities of daily living [5-7 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Dean Pepper, orthopaedic surgeon private rooms	Port Macquarie	New South Wales	Australia	2444

Sponsors and Collaborators

• The University of New South Wales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cameron Handford, Dr Cameron Handford, The University of New South Wales
• ClinicalTrials.gov Identifier: NCT02157220
• Other Study ID Numbers: HC12098
• First Posted: Jun 5, 2014
• Last Update Posted: Jun 5, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Jun 5, 2014