Cemented vs. Cementless Unicompartmental Knee Arthroplasty
A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2022
CompletedFirst Submitted
Initial submission to the registry
November 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
ExpectedJuly 24, 2023
July 1, 2023
3.5 years
November 9, 2022
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Society Score
Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.)
2 years postoperative
Study Arms (2)
Cementless
EXPERIMENTALCementless fixation partial knee replacement
Cemented
ACTIVE COMPARATORCemented fixation partial knee replacement
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age18-85 years old
- medial fixed bearing partial knee replacement
- bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22307, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Hopper
Anderson Orthopaedic Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2022
First Posted
November 15, 2022
Study Start
July 8, 2022
Primary Completion
December 30, 2025
Study Completion (Estimated)
December 30, 2026
Last Updated
July 24, 2023
Record last verified: 2023-07