ObesitySvNSNCT06019832
Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty
A study testing Total Knee Arthroplasty (TKA), Stemmed Tibial Implant and Non-stemmed tibial implant in people with Obesity and Aseptic Loosening, run by Jacob M. Elkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 99 years, women only
- Conditions the study is for
- Obesity, Aseptic Loosening, Varus Collapse
- What is being tested?
- Total Knee Arthroplasty (TKA), Stemmed Tibial Implant and Non-stemmed tibial implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty
- Age 40 or older
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa Health Care Medical Center North Liberty
North Liberty, Iowa, 52317
About this study
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.
Read the 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 age 40 and older 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 (2-3 weeks, 8-10 weeks, 1 year, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 8-10 weeks and one year. In addition to this, the study participants will be evaluated at 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit.
- Conditions
- Obesity, Aseptic Loosening, Varus Collapse
- Being tested
- Total Knee Arthroplasty (TKA), Stemmed Tibial Implant, Non-stemmed tibial implant
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty (TKA)Procedure or surgery
Both study arms will undergo TKA
Stemmed Tibial ImplantDevice
A stemmed tibial implant.
Non-stemmed tibial implantDevice
A non-stemmed tibial implant.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Stemmed Tibial Implant | Active comparator | This study group will receive a stemmed tibial implant as part of their TKA. Receives: 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. Receives: Procedure: Total Knee Arthroplasty (TKA); Device: Non-stemmed tibial implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Varus Collapse
The investigators will track rate of varus collapse.
Measured: up to 5 years post surgery
Aseptic loosening
The investigators will track rates of aseptic loosening.
Measured: up to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start14 Aug 2023
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob M. Elkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob M. Elkins, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019832
- Sponsor's protocol ID
- 202303366
- Acronym
- SvNS
- Status last verified
- May 2026
- First submitted
- 24 Aug 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06019832
- Acronym / sponsor ID
- SvNS / 202303366
- Conditions
- Obesity, Aseptic Loosening, Varus Collapse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Jacob M. ElkinsUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 age 40 and older 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 (2-3 weeks, 8-10 weeks, 1 year, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 8-10 weeks and one year. In addition to this, the study participants will be evaluated at 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Stemmed Tibial Implant | Active comparator | Procedure: Total Knee Arthroplasty (TKA), Device: Stemmed Tibial ImplantThis study group will receive a stemmed tibial implant as part of their TKA. |
| Group B: Non-Stemmed Tibial implant | Active comparator | Procedure: Total Knee Arthroplasty (TKA), Device: Non-stemmed tibial implantThis study group will receive a non-stemmed tibial implant as part of their TKA. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty
- Age 40 or older
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee Arthroplasty (TKA)Both study arms will undergo TKA | Procedure or surgery | Group A: Stemmed Tibial Implant, Group B: Non-Stemmed Tibial implant |
| Stemmed Tibial ImplantA stemmed tibial implant. | Device | Group A: Stemmed Tibial Implant |
| Non-stemmed tibial implantA non-stemmed tibial implant. | Device | Group B: Non-Stemmed Tibial implant |
Primary outcome
Varus Collapse
Time frame: up to 5 years post surgery
The investigators will track rate of varus collapse.
Aseptic loosening
Time frame: up to 5 years post surgery
The investigators will track rates of aseptic loosening.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty (TKA), Stemmed Tibial Implant and Non-stemmed tibial implant in people with Obesity and Aseptic Loosening, run by Jacob M. Elkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Varus Collapse (time frame: up to 5 years post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.