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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cemented vs. Cementless Unicompartmental Knee Arthroplasty

NCT05616884

Partial Knee Replacement

ENROLLING_BY_INVITATION NA

A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty

NCT00589147

Total Knee Arthroplasty

COMPLETED NA

Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty

NCT00589108

Degenerative Joint Disease

COMPLETED NA

Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study

NCT01041937

Osteoarthritis Post-traumatic Osteoarthritis Rheumatoid Arthritis

COMPLETED NA

NexGen TM Tibia Clinical Outcomes Study

NCT03272373

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis +4 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cemented fixation

Nexgen High-Flexion Knee Replacement System using Cemented Fixation

Group Type OTHER

High-Flexion Knee Replacement System using Cemented Fixation

Intervention Type DEVICE

Cementless fixation

Nexgen High-Flexion Knee Replacement System using Cementless Fixation

Group Type OTHER

High-Flexion Knee Replacement System using Cementless Fixation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-Flexion Knee Replacement System using Cemented Fixation

Intervention Type DEVICE

High-Flexion Knee Replacement System using Cementless Fixation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No