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

A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: High-Flexion Knee Replacement System using Cemented Fixation; Device: High-Flexion Knee Replacement System using Cementless Fixation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cemented fixation; Nexgen High-Flexion Knee Replacement System using Cemented Fixation	Device: High-Flexion Knee Replacement System using Cemented Fixation
Other: Cementless fixation; Nexgen High-Flexion Knee Replacement System using Cementless Fixation	Device: High-Flexion Knee Replacement System using Cementless Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic analysis	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.	4 week
Radiographic analysis	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.	1 year
Radiographic analysis	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.	2 year
Radiographic analysis	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.	5 year
Radiographic analysis	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.	10 year
Radiographic analysis	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.	15 year
Complications	The number and type of adverse events will be monitored to assess safety.	Date of surgery
Complications	The number and type of adverse events will be monitored to assess safety.	4 week
Complications	The number and type of adverse events will be monitored to assess safety.	4 month
Complications	The number and type of adverse events will be monitored to assess safety.	1 year
Complications	The number and type of adverse events will be monitored to assess safety.	2 year
Complications	The number and type of adverse events will be monitored to assess safety.	5 year
Complications	The number and type of adverse events will be monitored to assess safety.	10 year
Complications	The number and type of adverse events will be monitored to assess safety.	15 year
Radiographic analysis	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.	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	4 week
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	1 year
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	2 year
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	5 year
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	10 year
Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	15 year
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	4 week
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	1 year
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	2 year
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	5 year
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	10 year
Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	15 year
Visual analog pain score	Pain score will be measured from a patient-assessed visual analog pain scale.	4 week
Visual analog pain score	Pain score will be measured from a patient-assessed visual analog pain scale.	4 month

Collaborators and Investigators

• Sponsor: Anderson Orthopaedic Research Institute
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Kevin B Fricka, MD, Anderson Orthopaedic Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 2, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (Estimated): September 3, 2010

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: total knee replacement; total knee arthroplasty; cementless TKA; high flexion; trabecular metal
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AORI2010-0105