Clinical trial NCT01194817: A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
total knee replacement
cementless TKA
high flexion
trabecular metal
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2010-09-03
Enrollment: 100
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiographic analysis
timeFrame: 4 week
measure: Radiographic analysis
timeFrame: 1 year
measure: Radiographic analysis
timeFrame: 2 year
measure: Radiographic analysis
timeFrame: 5 year
measure: Radiographic analysis
timeFrame: 10 year
measure: Radiographic analysis
timeFrame: 15 year
measure: Complications
timeFrame: Date of surgery
measure: Complications
timeFrame: 4 week
measure: Complications
timeFrame: 4 month
measure: Complications
timeFrame: 1 year
measure: Complications
timeFrame: 2 year
measure: Complications
timeFrame: 5 year
measure: Complications
timeFrame: 10 year
measure: Complications
timeFrame: 15 year
measure: Radiographic analysis
timeFrame: 4 month
Secondary outcomes:
measure: Knee Society Score
timeFrame: 4 week
measure: Knee Society Score
timeFrame: 1 year
measure: Knee Society Score
timeFrame: 2 year
measure: Knee Society Score
timeFrame: 5 year
measure: Knee Society Score
timeFrame: 10 year
measure: Knee Society Score
timeFrame: 15 year
measure: Oxford Knee Score
timeFrame: 4 week
measure: Oxford Knee Score
timeFrame: 1 year
measure: Oxford Knee Score
timeFrame: 2 year
measure: Oxford Knee Score
timeFrame: 5 year
measure: Oxford Knee Score
timeFrame: 10 year
measure: Oxford Knee Score
timeFrame: 15 year
measure: Visual analog pain score
timeFrame: 4 week
measure: Visual analog pain score
timeFrame: 4 month
Other outcomes:
Locations:
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: Kevin B Fricka, MD
role: PRINCIPAL_INVESTIGATOR
References: