Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04730557
Brief Summary:
OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. The first objective of the study is to determine the effects of obesity on cartilage composition and function. The second objective of the study is to determine whether weight loss restores cartilage composition and function. Study activities would require getting MR Imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. The study will target a population age group between 18 and 45 years with a BMI greater than or equal to 29. Data analyses will be blinded to reduce potential bias. All subjects participating in this study will be informed of the risks involved and sign an IRB-approved consent form.
Detailed Description:
Appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see Data Analysis and Statistical Considerations). We will recruit and enroll obese (BMI ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms OA, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. All inclusion criteria specific to knee injury, OA, and alignment will be verified by MRI scan. All participants in this study will be informed of the risks involved. Upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their BMI. Potential participants will be pre-screened by phone using a phone script with a list of questions. Once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.
Study:
NCT04730557
Study Brief:
Protocol Section:
NCT04730557