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Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty

NCT06019832 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-20

No results posted yet for this study

Summary

The purpose of this study is to compare rates of varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will review the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.

Conditions

  • Obesity
  • Aseptic Loosening
  • Varus Collapse

Interventions

PROCEDURE

Total Knee Arthroplasty (TKA)

Both study arms will undergo TKA

DEVICE

Stemmed Tibial Implant

A stemmed tibial implant.

DEVICE

Non-stemmed tibial implant

A non-stemmed tibial implant.

Sponsors & Collaborators

  • Jacob M. Elkins

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2032-12-31
Completion
2032-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019832 on ClinicalTrials.gov