Cemented vs. Cementless Unicompartmental Knee Arthroplasty

NCT ID: NCT05616884

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2026-12-30

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.

Conditions

Partial Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cementless

Cementless fixation partial knee replacement

Group Type: EXPERIMENTAL

Cementless fixation

Intervention Type: 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.

Cemented

Cemented fixation partial knee replacement

Group Type: ACTIVE_COMPARATOR

Cementless fixation

Intervention Type: 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.

Interventions

Cementless fixation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kevin B. Fricka, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Hopper

Role: STUDY_CHAIR

Anderson Orthopaedic Research Institute

Locations

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Countries

United States

Other Identifiers

PRJ123

Identifier Type: -

Identifier Source: org_study_id