Cemented vs. Cementless Unicompartmental Knee Arthroplasty

Part of paid clinical trials in Alexandria, Virginia.

Sponsor
Anderson Orthopaedic Research Institute
Study ID
NCT05616884
Status
Enrolling By Invitation

Conditions

  • Partial Knee Replacement

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Cementless fixation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
Jul 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cementless
    Cementless fixation partial knee replacement
  • Active Comparator: Cemented
    Cemented fixation partial knee replacement

Primary Outcome Measure

Knee Society Score [ Time Frame: 2 years postoperative ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anderson Orthopaedic Research InstituteAlexandriaVirginia22307-

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Anderson Orthopaedic Research Institute· Alexandria, VA

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