A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Knee Society Score
Study Overview
Brief Summary
The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.
Detailed Description
This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age18-85 years old
- •medial fixed bearing partial knee replacement
- •bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.
Exclusion Criteria
- •Non-English speakers
- •current smokers
- •grossly porotic bone
- •advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
- •previous high tibial osteotomy with prior hardware
- •patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts
Arms & Interventions
Cementless
Cementless fixation partial knee replacement
Intervention: Cementless fixation (Procedure)
Cemented
Cemented fixation partial knee replacement
Intervention: Cementless fixation (Procedure)
Outcomes
Primary Outcomes
Knee Society Score
Time Frame: 2 years postoperative
Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.)
Secondary Outcomes
No secondary outcomes reported
Investigators
Kevin B. Fricka, MD
Principal Investigator
Anderson Orthopaedic Research Institute