Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03731676
• Other study ID #: 11119
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2000
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Osteoarthritis

2. Rheumatoid or other inflammatory arthritis

3. Post-traumatic arthritis

4. Juvenile rheumatoid arthritis

5. Avascular necrosis

Exclusion Criteria:

1. History of recent/active joint sepsis

2. Charcot neuropathy

3. Psycho-social disorders that would limit rehabilitation

4. Metabolic disorders of calcified tissues, such as Paget's disease

5. Joint replacement due to autoimmune disorders

6. Skeletal immaturity

7. Ligamentous laxity requiring a constrained prosthesis

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Fixed bearing total knee arthroplasty
Fixed bearing total knee arthroplasty
• Rotating platform total knee arthroplasty
Rotating platform total knee arthroplasty

Locations

Country	Name	City	State
United States	Dr. William Hopkinson	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
William Hopkinson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Status over time	Knee Society Clinical Rating Scale	Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Primary	Change in Osteoarthritis Status over time	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items)	Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Primary	Change in Overall Health Status over time	Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health.	Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Secondary	Change in Satisfaction of Knee over time	4-point Likert scale used to assess satisfaction with knee Scale-1. Extremely satisfied 2. Satisfied 3. Unsatisfied 4. Extremely unsatisfied	Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.