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New treatment option for Knee Osteoarthritis
Official title Total Knee Arthroplasty in Varus Deformity
ClinicalTrials.gov ID: NCT07465484
What this study is testing
- What it's testing
- For the first time, a comparative analysis of the limb axis in patients with unilateral knee OA will be conducted compared to the contralateral uninjured side using Multisliced computed tomography (MSCT) and vertical CT (weight-bearing CT). This analysis will identify the pathological and physiological degrees of varus in patients with unilateral gonarthrosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS...
- Varus deformity of the lower limb (HKA angle \ 3°)
- Anesthesia risk according to the ASA scale of no more than III.
- BMI less than 35 kg/m2.
- Patient must be monitored throughout the entire study period (12 months).
You likely can't join if
- Body mass index \> 40 kg/m².
- Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
- Impaired weight-bearing ability of the contralateral limb.
- Presence of metal implants or foreign bodies in the lower extremities.
- Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
- Patient refusal to participate in the study.
See the full eligibility criteria
- Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS scale.
- Varus deformity of the lower limb (HKA angle \ 3°)
- Anesthesia risk according to the ASA scale of no more than III.
- BMI less than 35 kg/m2.
- Patient must be monitored throughout the entire study period (12 months).
- Patient must be mentally competent and compliant.
- Patient must provide written informed consent to participate in the study.
- Body mass index \> 40 kg/m².
- Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
- Impaired weight-bearing ability of the contralateral limb.
- Presence of metal implants or foreign bodies in the lower extremities.
- Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
- Patient refusal to participate in the study.
- Patient failure to comply with the recommendations of the treating physician or the prescribed regimen.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.