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

Not Applicable

Active, not recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: High-Flexion Knee Replacement System using Cementless Fixation; Device: High-Flexion Knee Replacement System using Cemented Fixation

• Registration Number: NCT01194817
• Lead Sponsor: Anderson Orthopaedic Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cementless fixation	High-Flexion Knee Replacement System using Cementless Fixation	Nexgen High-Flexion Knee Replacement System using Cementless Fixation
Cemented fixation	High-Flexion Knee Replacement System using Cemented Fixation	Nexgen High-Flexion Knee Replacement System using Cemented Fixation

Primary Outcome Measures

Name	Time	Method
Complications	15 year	The number and type of adverse events will be monitored to assess safety.
Radiographic analysis	4 month	Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score	15 year	A patient reported questionnaire for assessing the outcome of knee surgery.
Knee Society Score	15 year	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Visual analog pain score	4 month	Pain score will be measured from a patient-assessed visual analog pain scale.