Cemented vs. Cementless Unicompartmental Knee Arthroplasty

Last updated: July 20, 2023
Sponsor: Anderson Orthopaedic Research Institute
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

Cementless fixation

Clinical Study ID

NCT05616884
PRJ123
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age18-85 years old
  • medial fixed bearing partial knee replacement
  • bone suitable for both cemented and cementless fixation after review of thepreoperative radiographs.

Exclusion

Exclusion Criteria:

  • Non-English speakers
  • current smokers
  • grossly porotic bone
  • advanced other compartment arthritis at the time of surgery necessitating a total kneearthroplasty (TKA)
  • previous high tibial osteotomy with prior hardware
  • patients who are randomized but are deemed unsuitable to receive the assigned implantby the surgeon due to bone quality or bone cuts

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Cementless fixation
Phase:
Study Start date:
July 08, 2022
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Anderson Orthopaedic Research Institute

    Alexandria, Virginia 22307
    United States

    Site Not Available

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