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NCT01027819 Clinical Trial

Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Osteoarthritis of Knee Clinical Trial

Official title:
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01027819
Other study ID # SNUHOSK09MBFB
Secondary ID SNUHOSK09MBFB
Status Active, not recruiting
Phase Phase 4
First received December 7, 2009
Last updated December 13, 2012
Start date November 2009

Study information
Verified date December 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Description:

Double blind, randomized prospective study Mobile or fixed bearing of the same company

- Mobile bearing group : group M

- Fixed bearing group : group F

Inclusion criteria

- patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

- Range of motion

- Complication

- Scorings

- KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

- Alignment angles in knee

- Positions of femoral and tibial components

- Position of patella

- Radiolucency

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- primary total knee arthroplasty

Exclusion Criteria:

- infection

- severe deformity in knee

- revision

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Mobile bearing
Mobile bearing in total knee arthroplasty
• Fixed bearing
Fixed bearing in total knee arthroplasty

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rotational Angle Between Femur and Tibia 2 weeks No
Secondary Knee Society Score 6 months No
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