Cemented vs. Cementless Unicompartmental Knee Arthroplasty

Not Applicable

• Conditions: Partial Knee Replacement
• Interventions: Procedure: Cementless fixation

• Registration Number: NCT05616884
• Lead Sponsor: Anderson Orthopaedic Research Institute

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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-08
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cementless	Cementless fixation	Cementless fixation partial knee replacement
Cemented	Cementless fixation	Cemented fixation partial knee replacement

Primary Outcome Measures

Name	Time	Method
Knee Society Score	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.)

Trial Locations

Locations (1)

Anderson Orthopaedic Research Institute; 🇺🇸 Alexandria, Virginia, United States