Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01335438

Enrollment

Registered

2011-04-14

Start date

1997-01-31

Completion date

2011-03-31

Last updated

2011-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total knee arthroplasty, cemented, cementless, fixation, posterior stabilized, cruciate retaining

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.

Interventions

DEVICECementless (Nexgen)

Cementless fixation of Nexgen CR TKR

DEVICECemented (Nexgen)

Cemented fixation of Nexgen CR TKR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026