A Prospective, Randomized Study Comparing Cemented and Cementless Total Knee Replacement: Results of a New Modular Trabecular Metal Tibial Component Using the NexGen System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Primary Endpoint
- Complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Complications
Time Frame: 15 year
The number and type of adverse events will be monitored to assess safety.
Radiographic analysis
Time Frame: 4 month
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.
Secondary Outcomes
- Oxford Knee Score(15 year)
- Knee Society Score(15 year)
- Visual analog pain score(4 month)
Investigators
Kevin B. Fricka, MD
Principal Investigator
Anderson Orthopaedic Research Institute