Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

Young Hoo Kim

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Device: Cementless (Nexgen); Device: Cemented (Nexgen)

Study type: Interventional

Funder types: Other

Identifiers

NCT01335438

TKRcementless

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Cementless Nexgen CR

Experimental group

Description:

Cementless fixation of Nexgen CR TKR

Treatment:

Device: Cementless (Nexgen)

Cemented Nexgen CR

Active Comparator group

Description:

Cemented fixation of Nexgen CR TKR

Treatment:

Device: Cemented (Nexgen)