Partial Knee Replacement
Conditions
Keywords
osteoarthritis, partial knee replacement, cementless
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.
Interventions
PROCEDURECementless fixation
Three dimensional printed porous metal, a biomaterial with morphological and mechanical properties that resemble those of native trabecular bone, is now being used for fixation of the tibial component in unicondylar knee arthroplasty. This can reliably achieve osseointegration into the tibia and could lead to a lower risk of aseptic loosening which is the leading cause of revision in partial knee replacements.
Sponsors
Anderson Orthopaedic Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized trial, unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 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.) |
Countries
United States
Outcome results
None listed