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Procedure

TKA Implant Types for Obesity-related Knee Surgery Complications

N/A

Recruiting

Research Sponsored by Jacob M. Elkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty

35 kg/m2 and above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post surgery

Awards & highlights

Study Summary

This trial compares rates of complications from knee surgery in obese women using different types of implants.

Who is the study for?

This trial is for female adult patients with severe osteoarthritis who are obese (BMI of 35 kg/m2 or above) and scheduled for total knee arthroplasty at the PI's clinic. It includes women using contraceptives or in menopause. Excluded are those with infections, high-risk medical conditions, previous knee surgery on the same site, or pregnant/capable of pregnancy.Check my eligibility

What is being tested?

The study aims to compare how well two types of tibial components - stemmed and non-stemmed - work in preventing varus collapse and aseptic loosening after total knee arthroplasty in obese female patients. The focus is on implant stability over time.See study design

What are the potential side effects?

Potential side effects from the surgical procedure may include pain at the implant site, swelling, infection risk post-surgery, issues related to anesthesia, blood clots, and possible complications leading to revision surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with severe knee arthritis scheduled for knee replacement surgery.

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My body mass index (BMI) is 35 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aseptic loosening

Varus Collapse

Trial Design

2Treatment groups

Active Control

Group I: Group A: Stemmed Tibial ImplantActive Control2 Interventions

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

Group II: Group B: Non-Stemmed Tibial implantActive Control2 Interventions

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jacob M. ElkinsLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass individuals over the age of seventy?

"This clinical trial is searching for older individuals aged 50 and above, yet below 99 years old."

Answered by AI

What type of individuals is this trial targeting?

"Candidates between the ages of 50 and 99 with obesity may be eligible for this study. Currently, 54 participants are sought after to complete it."

Answered by AI

Are there still vacancies for participants in this clinical experiment?

"As revealed on clinicaltrials.gov, this study is currently enrolling patients and has been since it was first uploaded on September 8th 2023. The latest update to the trial's records occurred August 30th 2023."

Answered by AI

How many individuals are being enrolled in this clinical experiment?

"Affirmative. The information posted on clinicaltrials.gov reveals that this medical study, first published on September 8th 2023, is presently enrolling participants. 54 volunteers are needed to join the trial from one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Analysis of Stem and Non-Stem Tibial Component

Jacob M. Elkins 2023. "Analysis of Stem and Non-Stem Tibial Component". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06019832.