A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement

Anderson Orthopaedic Research Institute

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Device: High-Flexion Knee Replacement System using Cementless Fixation; Device: High-Flexion Knee Replacement System using Cemented Fixation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01194817

AORI2010-0105

Details and patient eligibility

About

The purpose of this study is to compare the the Nexgen knee replacement system using cementless fixation with the same system using cemented fixation. At minimum 2-year follow-up, the hypothesis is that NexGen total knee arthroplasties using cementless and cemented fixation will demonstrate no differences in clinical outcome based on Oxford and Knee Society scores, patient-assessed visual analog pain, clinical complications, radiographic fixation and implant survivorship.

Enrollment: 100 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of osteoarthritis of the knee
• Patients undergoing primary total knee replacement

Exclusion criteria

• Age over 75 years old
• Prior unicondylar knee arthroplasty
• Grossly porotic bone or bone defects requiring bone grafting
• Bone cuts not sufficiently accurate for cementless fixation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Cemented fixation

Other group

Description:

Nexgen High-Flexion Knee Replacement System using Cemented Fixation

Treatment:

Device: High-Flexion Knee Replacement System using Cemented Fixation

Cementless fixation

Other group

Description:

Nexgen High-Flexion Knee Replacement System using Cementless Fixation

Treatment:

Device: High-Flexion Knee Replacement System using Cementless Fixation