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Clinical Trials/NCT01335438
NCT01335438
Completed
Phase 4

Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis

Young Hoo Kim1 site in 1 country96 target enrollmentJanuary 1997
ConditionsOsteoarthritis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Young Hoo Kim
Enrollment
96
Locations
1
Primary Endpoint
Improvement in Knee Society Knee Score
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

Detailed Description

Out comes measures were to determine: 1. whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis. 2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis. 3. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis 4. whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.

Registry
clinicaltrials.gov
Start Date
January 1997
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Young Hoo Kim
Responsible Party
Sponsor Investigator
Principal Investigator

Young Hoo Kim

Professor and Director

Ewha Womans University

Eligibility Criteria

Inclusion Criteria

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Outcomes

Primary Outcomes

Improvement in Knee Society Knee Score

Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

change in knee score will be compared with initial score, until mean follow up of 25 years.

Secondary Outcomes

  • Improvement in the Range of Motion(Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery)

Study Sites (1)

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