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New treatment option for Knee Osteoarthristis
Official title Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
ClinicalTrials.gov ID: NCT07356674
What this study is testing
- What it's testing
- This is a single-center clinical trial started by the study team. The goal is to compare two surgeries for people who have a varus knee alignment and a tear at the back attachment of the medial meniscus.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- Age 35 to 75 years, with no restriction on sex.
- Clinical features suggestive of a medial meniscus posterior root tear, including at least one of the following symptoms: knee locking, clicking, or...
- Varus knee deformity with a varus angle of less than 10 degrees, with the deformity predominantly originating from the tibia (i.e., medial proximal...
- Knee MRI demonstrates a medial meniscus posterior root tear.
- Knee radiographs show narrowing of the medial joint space, and Kellgren-Lawrence grade less than IV.
You likely can't join if
- Chronic knee locking (e.g., the participant cannot bend or fully straighten the knee).
- Kellgren-Lawrence grade IV knee osteoarthritis.
- Osteoarthritis or other conditions in other joints (e.g., hip or ankle) that may affect assessment of knee function.
- Known inflammatory diseases or other conditions that may affect knee function, including but not limited to: autoimmune diseases (e.g., rheumatoid...
- Target-knee instability (including but not limited to post-traumatic or congenital laxity) or inadequate ligament reconstruction, as judged by the...
- Any prior surgery on the target knee or on other joints of the ipsilateral lower limb.
See the full eligibility criteria
- Age 35 to 75 years, with no restriction on sex.
- Clinical features suggestive of a medial meniscus posterior root tear, including at least one of the following symptoms: knee locking, clicking, or medial knee pain; and at least one of the following signs: medial joint...
- Varus knee deformity with a varus angle of less than 10 degrees, with the deformity predominantly originating from the tibia (i.e., medial proximal tibial angle less than 87 degrees).
- Knee MRI demonstrates a medial meniscus posterior root tear.
- Knee radiographs show narrowing of the medial joint space, and Kellgren-Lawrence grade less than IV.
- Failure of conservative treatment (e.g., rest, medication, or physical therapy) for more than 1 month.
- Willing to accept randomization and able to understand and sign the informed consent form.
- For participants with bilateral deformity, the more severely deformed side will be selected as the operative (study) side.
- Chronic knee locking (e.g., the participant cannot bend or fully straighten the knee).
- Kellgren-Lawrence grade IV knee osteoarthritis.
- Osteoarthritis or other conditions in other joints (e.g., hip or ankle) that may affect assessment of knee function.
- Known inflammatory diseases or other conditions that may affect knee function, including but not limited to: autoimmune diseases (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus...
- Target-knee instability (including but not limited to post-traumatic or congenital laxity) or inadequate ligament reconstruction, as judged by the investigator.
- Any prior surgery on the target knee or on other joints of the ipsilateral lower limb.
- Serious cardiac disease; hepatic impairment (aspartate aminotransferase or alanine aminotransferase at least 3 times the upper limit of normal, or total serum bilirubin at least 1.5 times the upper limit of normal)...
- Body mass index at least 30 kg/m².
- Pregnant or breastfeeding women, or participants (including men and women) unwilling to use contraception during the study period.
- Participation in another clinical study within 3 months prior to enrollment (excluding registry studies).
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
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, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. 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.