A Prospective Longitudinal Observational Study of the Effects of Bariatric Surgery and Weight Loss on Spinopelvic Alignment and Global Sagittal Balance: Serial Evaluation of Spinal, Pelvic, and Spinopelvic Radiographic Parameters Before Surgery and at 3, 6, and 12 Months After Surgery in Patients With Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Sagittal Vertical Axis (SVA)
研究概览
简要总结
The goal of this prospective observational study is to understand how major weight loss after bariatric surgery may be associated with changes in the way the spine and pelvis are aligned in adults with morbid obesity.
The spine and pelvis work together to support the body and help maintain balance during standing and walking. In people with severe obesity, increased body weight and changes in body shape may affect posture, the position of the pelvis, the curves of the spine, and the way the upper body is balanced over the pelvis. Bariatric surgery can result in substantial weight loss, but it is not yet fully understood how these changes in body weight may affect the relationship between the spine and pelvis over time.
This study will follow patients undergoing bariatric surgery and will evaluate them before surgery and again at approximately 3, 6, and 12 months after surgery. The study is observational. This means that the researchers will observe, measure, and record changes occurring during the patients' clinical course rather than assigning participants to a specific treatment for the purpose of this study.
The main question of the study is whether spinopelvic alignment and overall body balance change during the first year after bariatric surgery as patients lose weight.
"Spinopelvic alignment" refers to the relationship between the spine and the pelvis. The pelvis forms the base on which the spine is positioned, and changes in pelvic position can be related to changes in the curves and orientation of the spine. "Sagittal balance" refers to how the head, trunk, spine, and pelvis are balanced from front to back when the body is viewed from the side.
Researchers will evaluate measurements describing the position and orientation of the pelvis, the curvature and alignment of the spine, and the relationship between the spine and pelvis. Measurements obtained before bariatric surgery will be compared with those obtained at approximately 3, 6, and 12 months after surgery.
By following the same patients at several different time points, the researchers will be able to determine whether any changes occur early after surgery, develop gradually as weight loss continues, or remain relatively stable throughout the first postoperative year.
The study will also examine the relationship between postoperative weight loss and changes in spinopelvic measurements. Patients may respond differently to major weight loss. Some people may develop measurable changes in posture or spinal and pelvic alignment, while others may show little or no change. The purpose of the study is therefore not to assume that weight loss will improve every spinal or pelvic measurement, but to objectively describe what happens to these measurements during the period of substantial weight reduction after bariatric surgery.
Understanding these changes may be important because body weight, posture, spinal curvature, pelvic position, and mechanical loading are closely related. Changes in how the body is balanced may potentially influence the mechanical demands placed on the spine, pelvis, and surrounding muscles and joints.
The results may improve understanding of the musculoskeletal effects of severe obesity and major weight loss. They may also provide information for future research on the relationship between obesity, weight reduction, posture, spinal alignment, pelvic position, spinal balance, and musculoskeletal health.
For patients and families, the study can be summarized simply as follows: the researchers want to find out whether losing a substantial amount of weight after bariatric surgery changes the way the spine and pelvis are positioned and balanced. Measurements taken before surgery will be compared with measurements taken during follow-up at 3, 6, and 12 months. By observing the same patients throughout the first year after surgery, the researchers hope to better understand how the spine and pelvis adapt as body weight decreases.
详细描述
Obesity is a complex chronic disease associated with substantial metabolic, cardiovascular, respiratory, and musculoskeletal consequences. In addition to increasing the absolute mechanical load transmitted through the axial and appendicular skeleton, severe obesity may alter body posture, trunk position, pelvic orientation, spinal curvature, and global balance. These adaptations may develop as compensatory mechanisms that allow an individual to maintain an upright posture and preserve the center of gravity within the base of support despite marked changes in body mass and body habitus.
Bariatric surgery is an established treatment option for appropriately selected patients with severe or morbid obesity and can result in substantial and progressive weight reduction. Although the metabolic and systemic effects of bariatric surgery have been extensively investigated, the longitudinal effects of major postoperative weight loss on spinal and pelvic alignment remain less clearly characterized. In particular, the extent to which changes in body mass are accompanied by changes in pelvic orientation, lumbar and thoracic alignment, spinopelvic relationships, and global sagittal balance has not been fully established.
The present prospective longitudinal observational study is designed to evaluate changes in spinopelvic alignment and sagittal balance in patients with morbid obesity undergoing bariatric surgery. Participants will be evaluated before surgery and subsequently at approximately 3, 6, and 12 months after surgery. This repeated-measures design will allow the same individuals to serve as their own longitudinal reference and will enable assessment of both the magnitude and the temporal pattern of postoperative changes.
Scientific Rationale Maintenance of an energy-efficient upright posture requires a coordinated relationship between the spine, pelvis, lower extremities, and surrounding musculature. The pelvis represents the mechanical link between the spine and lower extremities and plays a central role in sagittal balance. Variations in pelvic orientation may be accompanied by compensatory changes in lumbar lordosis, thoracic alignment, hip position, and overall trunk inclination.
In individuals with severe obesity, increased abdominal and truncal mass may shift the body's center of gravity and increase the moment arms acting on the lumbar spine and pelvis. Compensatory postural mechanisms may therefore develop to maintain balance. These mechanisms can potentially include changes in pelvic tilt, sacral orientation, lumbar curvature, thoracic curvature, and global trunk position.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients with morbid obesity who are scheduled to undergo bariatric surgery according to routine clinical indications.
- •Ability to stand independently for standardized weight-bearing radiographic assessment.
- •Availability of an appropriate preoperative standing whole-spine radiograph for spinopelvic measurements.
- •Planned postoperative clinical and radiographic follow-up at approximately 3, 6, and 12 months.
- •Ability and willingness to participate in the prospective follow-up protocol.
排除标准
- •Previous spinal fusion, spinal instrumentation, or major spinal deformity surgery that may substantially alter spinopelvic alignment.
- •Previous major pelvic surgery or structural pelvic disorder preventing reliable spinopelvic measurements.
- •Neurological or neuromuscular disorders that substantially affect standing posture or sagittal balance.
- •Inability to obtain technically adequate standardized standing radiographs.
- •Pregnancy at a time when radiographic assessment would otherwise be required.
- •Development of a major spinal, pelvic, or lower-extremity condition or surgery during follow-up that may independently alter spinopelvic alignment.
- •Incomplete or unavailable radiographic data required for longitudinal analysis.
研究组 & 干预措施
Patients Undergoing Bariatric Surgery
Adults with morbid obesity undergoing bariatric surgery as part of routine clinical care will be prospectively followed. Spinopelvic alignment, spinal and pelvic radiographic parameters, and global sagittal balance will be evaluated before surgery and at approximately 3, 6, and 12 months after surgery to assess longitudinal changes associated with postoperative weight loss.
结局指标
主要结局
Change From Baseline in Sagittal Vertical Axis (SVA)
时间窗: Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery
Sagittal Vertical Axis (SVA) will be measured in millimeters on standing lateral whole-spine radiographs as the horizontal distance between the C7 plumb line and the posterosuperior corner of the S1 vertebral body. Positive values indicate anterior translation of the trunk relative to the sacrum. Change from the preoperative baseline will be calculated at each postoperative follow-up.
次要结局
- Change From Baseline in Pelvic Incidence-Lumbar Lordosis (PI-LL) Mismatch(Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery)
- Change From Baseline in Pelvic Tilt (PT)(Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery)
- Change From Baseline in Sacral Slope (SS)(Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery)
- Change From Baseline in Lumbar Lordosis (LL)(Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery)
- Change From Baseline in T1 Pelvic Angle (TPA)(Baseline (preoperative), and 3, 6, and 12 months after bariatric surgery)