Cemented vs. Cementless Unicompartmental Knee Arthroplasty

Anderson Orthopaedic Research Institute

Status

Invitation-only

Conditions

Partial Knee Replacement

Treatments

Procedure: Cementless fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT05616884

PRJ123

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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