Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments high-flexion knee replacement system using cemented fixation, high-flexion knee replacement system using cementless fixation
Sponsor Anderson Orthopaedic Research Institute
Collaborator Zimmer, Inc.
Start date April 2010
End date December 2026
Trial size 100 participants
Trial identifier NCT01194817, AORI2010-0105

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Nexgen High-Flexion Knee Replacement System using Cemented Fixation
high-flexion knee replacement system using cemented fixation
(Other)
Nexgen High-Flexion Knee Replacement System using Cementless Fixation
high-flexion knee replacement system using cementless fixation

Primary Outcomes

Measure
Radiographic analysis
time frame: 4 week
Radiographic analysis
time frame: 1 year
Radiographic analysis
time frame: 2 year
Radiographic analysis
time frame: 5 year
Radiographic analysis
time frame: 10 year
Radiographic analysis
time frame: 15 year
Complications
time frame: Date of surgery
Complications
time frame: 4 week
Complications
time frame: 4 month
Complications
time frame: 1 year
Complications
time frame: 2 year
Complications
time frame: 5 year
Complications
time frame: 10 year
Complications
time frame: 15 year
Radiographic analysis
time frame: 4 month

Secondary Outcomes

Measure
Knee Society Score
time frame: 4 week
Knee Society Score
time frame: 1 year
Knee Society Score
time frame: 2 year
Knee Society Score
time frame: 5 year
Knee Society Score
time frame: 10 year
Knee Society Score
time frame: 15 year
Oxford Knee Score
time frame: 4 week
Oxford Knee Score
time frame: 1 year
Oxford Knee Score
time frame: 2 year
Oxford Knee Score
time frame: 5 year
Oxford Knee Score
time frame: 10 year
Oxford Knee Score
time frame: 15 year
Visual analog pain score
time frame: 4 week
Visual analog pain score
time frame: 4 month

Eligibility Criteria

Male or female participants up to 75 years old.

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

Additional Information

Official title A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System
Principal investigator Kevin B Fricka, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Anderson Orthopaedic Research Institute.