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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01194817
• Other study ID #: AORI2010-0105
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• High-Flexion Knee Replacement System using Cemented Fixation

• High-Flexion Knee Replacement System using Cementless Fixation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute	Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	Date of surgery
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	4 week
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	4 month
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	1 year
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	2 year
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	5 year
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	10 year
Primary	Complications	The number and type of adverse events will be monitored to assess safety.	15 year
Primary	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	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	4 week
Secondary	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	1 year
Secondary	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	2 year
Secondary	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	5 year
Secondary	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	10 year
Secondary	Knee Society Score	A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.	15 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	4 week
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	1 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	2 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	5 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	10 year
Secondary	Oxford Knee Score	A patient reported questionnaire for assessing the outcome of knee surgery.	15 year
Secondary	Visual analog pain score	Pain score will be measured from a patient-assessed visual analog pain scale.	4 week
Secondary	Visual analog pain score	Pain score will be measured from a patient-assessed visual analog pain scale.	4 month