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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01194817

Enrollment

100

Registered

2010-09-03

Start date

2010-04-30

Completion date

2026-12-31

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplasty, total knee replacement, cementless TKA, high flexion, trabecular metal

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.

Interventions

DEVICEHigh-Flexion Knee Replacement System using Cemented Fixation

DEVICEHigh-Flexion Knee Replacement System using Cementless Fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Radiographic analysis	4 week	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.
Complications	Date of surgery	The number and type of adverse events will be monitored to assess safety.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026