Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Cementless (Nexgen); Device: Cemented (Nexgen)

• Registration Number: NCT01335438
• Lead Sponsor: Young Hoo Kim

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.

Study Timeline

• Study Start: 1997-01
• Primary Completion: 1998-02
• Study Completion: 2011-03
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cementless Nexgen CR	Cementless (Nexgen)	Cementless fixation of Nexgen CR TKR
Cemented Nexgen CR	Cemented (Nexgen)	Cemented fixation of Nexgen CR TKR

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	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 Outcome Measures

Name	Time	Method
Improvement in the Range of Motion	Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery	change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hosptial; 🇰🇷 Seoul, Korea, Republic of