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

NCT06019832 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 202303366
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Varus Collapse

  The investigators will track rate of varus collapse.

  up to 5 years post surgery

• Aseptic loosening

  The investigators will track rates of aseptic loosening.

  up to 5 years post surgery

Study Arms (2)

Group A: Stemmed Tibial Implant

ACTIVE COMPARATOR

This study group will receive a stemmed tibial implant as part of their TKA.

Procedure: Total Knee Arthroplasty (TKA); Device: Stemmed Tibial Implant

Group B: Non-Stemmed Tibial implant

ACTIVE COMPARATOR

This study group will receive a non-stemmed tibial implant as part of their TKA.

Procedure: Total Knee Arthroplasty (TKA); Device: Non-stemmed tibial implant

Interventions

Total Knee Arthroplasty (TKA) PROCEDURE

Both study arms will undergo TKA

Group A: Stemmed Tibial Implant; Group B: Non-Stemmed Tibial implant

Stemmed Tibial Implant DEVICE

A stemmed tibial implant.

Group A: Stemmed Tibial Implant

Non-stemmed tibial implant DEVICE

A non-stemmed tibial implant.

Group B: Non-Stemmed Tibial implant

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty
• Age 40 or older
• kg/m2 and above
• Only patients from the PI's clinic will be included.
• Women who are still menstruating and are currently on contraceptives and women who are in menopause.

You may not qualify if:

• Patients who have some active local or widespread infection (including secondary or inflammatory osteoarthritis)
• medical conditions that put them at risk of complications or death during and after the study would not be eligible for surgery
• Patients with previous knee surgery on arthroplasty site will be excluded
• Pregnant patients and women who are capable of getting pregnant

Sponsors & Collaborators

• Jacob M. Elkins: lead

Study Sites (1)

Iowa Health Care Medical Center North Liberty

North Liberty, Iowa, 52317, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)