A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Partial Knee Replacement
- Sponsor
- Anderson Orthopaedic Research Institute
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Knee Society Score
- Status
- Enrolling by Invitation
- Last Updated
- 2 years ago
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.
Investigators
Kevin B. Fricka, MD
Principal Investigator
Anderson Orthopaedic Research Institute
Eligibility Criteria
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
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.)