Cemented vs. Cementless Unicompartmental Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cementless fixation.
- Who it may be relevant to
- Registry conditions: Partial Knee Replacement. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
Overview
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
- Procedure Cementless 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.
Primary outcome measures
- Knee Society Score [Time frame: 2 years postoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Anderson Orthopaedic Research Institute — Alexandria
Identifiers
NCT: NCT05616884 · PRJ123