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OpenTrials
Enrolling by Invitation

NCT Number: NCT05616884

Cemented vs. Cementless Unicompartmental Knee Arthroplasty

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.

Enrolling by Invitation

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Key information

Conditions

Partial Knee Replacement Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Knee Society Score

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Anderson Orthopaedic Research Institute

Other

Registry information

Official study title

A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2022
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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