跳至主要内容
临床试验/NCT02408276
NCT02408276已完成不适用

Longitudinal Evaluation of Hip Cartilage Degeneration: the Effect of Femoroacetabular Impingement

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
degree of cartilage degeneration

研究概览

简要总结

Femoroacetabular impingement (FAI) is one of the most common mechanisms leading to the development of early cartilage and labral damage in the non-dysplastic hip. Anatomic abnormalities of the proximal femur and/or acetabulum result in repetitive injury during dynamic hip motion, leading to abnormal regional loading of the femoral head-neck junction against the acetabular rim. The resulting damage to the cartilage, labrum, and surrounding capsular structures predispose the patient to developing hip pain and early osteoarthritic changes. Clinically, patients with FAI are a heterogeneous group, with a wide array of presentation from pain to instability that may or may not be related to activity. To date no studies have identified specific prognostic indicators associated with successful surgical treatment of FAI, leaving surgeons without adequate criteria to determine which patients are best suited for arthroscopy. The investigators propose to address this critical knowledge gap by identifying the patient characteristics and morphological features of the hip that are associated with the optimal clinical outcomes in patients undergoing hip arthroscopy or non-operative management for treatment of suspected FAI in order to establish a treatment algorithm for FAI patients.

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
10 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients 35 years of age or younger enrolled in the HSS Hip Preservation Registry prior to September 30, 2016 with an MRI confirmed diagnosis of FAI will be eligible for inclusion in this study regardless of surgery status.
  • Patients who agree to participate must complete a baseline questionnaire consisting of: 1) Modified Harris Hip Score (MHHS), an overall measure of hip condition; 2) the Hip Outcome Score (HOS), a measure developed specifically for younger active patients that measures quality of life and levels of sports and recreation; and 3) International Hip Outcome Tool (iHOT33), a newly developed hip specific outcome score, which measures a number of subscores relating to physical and social functioning with hip problems.

排除标准

  • Patients over age 35 will be excluded as the focus of this study is early changes that may predispose to later degenerative changes.
  • Patients undergoing revision hip arthroscopy as their first treatment in the Registry will not be eligible, as these are patients who have failed initial therapy.
  • Patients with no complete questionnaires at any time point will be excluded.

结局指标

主要结局

degree of cartilage degeneration

时间窗: 5 years post operation

degree of cartilage degeneration at 5 years post-presentation based on changes in cartilage morphology assessed using MRI (a two-dimensional fast spin echo sequence in the coronal and sagittal planes).

次要结局

  • dGEMERIC MRI measurements(2 year post operation)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验