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Analysis of Stem and Non-Stem Tibial Component

Primary Purpose

Obesity, Aseptic Loosening, Varus Collapse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty (TKA)
Stemmed Tibial Implant
Non-stemmed tibial implant
Sponsored by
Jacob M. Elkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria: Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty 35 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. Exclusion Criteria: 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

Sites / Locations

  • University of Iowa Hospitals and ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: Stemmed Tibial Implant

Group B: Non-Stemmed Tibial implant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Varus Collapse
The investigators will track rate of varus collapse.
Aseptic loosening
The investigators will track rates of aseptic loosening.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2023
Last Updated
September 27, 2023
Sponsor
Jacob M. Elkins
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1. Study Identification

Unique Protocol Identification Number
NCT06019832
Brief Title
Analysis of Stem and Non-Stem Tibial Component
Official Title
Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
July 19, 2025 (Anticipated)
Study Completion Date
July 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob M. Elkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The purpose of this study is to identify varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this study 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. Female patients with BMI of 35 kg/m2 and above will be randomized into two groups: the non-stem tibial component (control group) and the stem tibial component (treatment group). Previous studies done in the past in normal weight patients showed that there is little or no advantage in using the stem tibial implants over the non-stem ones. Theoretically, biomechanical studies have suggested that there may be improved fixation and load distribution with the use of stem tibial implants. Thus, it is necessary to see if there is any difference between both implant options among female patients who have the highest incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer than the non-stem ones. They are designed to extends deeper into the tibia to enhance fixation and improve load distribution. The use of either stem tibial implants is usually based on patients' characteristics and surgeons' preference. Following informed consent, standard perioperative patient-reported metrics will be collected (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [KOOS-JR], American Knee Society score, and Patient-Reported Outcome Measurement Information System 10 [PROMIS-10]) before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 12 weeks and one year. In addition to this, the study participants will be evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Aseptic Loosening, Varus Collapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Stemmed Tibial Implant
Arm Type
Active Comparator
Arm Description
This study group will receive a stemmed tibial implant as part of their TKA.
Arm Title
Group B: Non-Stemmed Tibial implant
Arm Type
Active Comparator
Arm Description
This study group will receive a non-stemmed tibial implant as part of their TKA.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty (TKA)
Intervention Description
Both study arms will undergo TKA
Intervention Type
Device
Intervention Name(s)
Stemmed Tibial Implant
Intervention Description
A stemmed tibial implant
Intervention Type
Device
Intervention Name(s)
Non-stemmed tibial implant
Intervention Description
non-stemmed tibial implants
Primary Outcome Measure Information:
Title
Varus Collapse
Description
The investigators will track rate of varus collapse.
Time Frame
up to 5 years post surgery
Title
Aseptic loosening
Description
The investigators will track rates of aseptic loosening.
Time Frame
up to 5 years post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty 35 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Elkins, MD, PHD
Phone
+1 319 335 7529
Email
jacob-elkins@uiowa.edu
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob M Elkins, MD, PhD
Email
jacob-elkins@uiowa.edu

12. IPD Sharing Statement

Learn more about this trial

Analysis of Stem and Non-Stem Tibial Component

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