Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 747
- 试验地点
- 13
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
研究概览
简要总结
The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. The proposed study will investigate critical patient, disease, and surgical treatment predictors of FAI surgery outcomes.
详细描述
PROCEDURES:
Potential participants will be identified at their initial PI's outpatient clinic at which the PI will meet with the patient and determine if the patient should be treated surgically due to a diagnosis of FAI. Once the PI identifies the patient as a surgical candidate, the research study team in the clinic will approach the patient with study information to discuss. If the patient would like to participate, the patient will sign an informed consent document (assent document for minors) and begin completing study-specific information. If the patient would like to take the study documents home to consider participation, the research team member will provide his/her contact information to the patient.
SPECIFIC AIMS:
- Determine the predictors of mid-term patient-reported outcomes (PROs) and treatment failures in an established prospective longitudinal cohort of Femoroacetabular Impingement (FAI) surgeries.
- Determine the impact of three-dimensional femoral and acetabular morphology on PROs at short-term follow-up in a novel prospective longitudinal cohort of arthroscopic FAI surgery.
- Determine if the new Patient-Reported Outcome Measurement Information System (PROMIS) correlates with legacy PROs in patients undergoing FAI surgery.
DATA COLLECTION:
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
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 - 40 years
- •Skeletally Mature
- •Failure of 6 weeks of conservative treatment
- •Primary surgery (Hip Arthroscopic Treatment)
- •a. Surgical treatment of FAI with hip arthroscopy
- •Tonnis 0 -1 OA, with greater than 2 mm of joint space
- •Clinical diagnosis of FAI (cam or combined; alpha >50 degrees)
排除标准
- •Not a surgical candidate
- •Skeletally Immature
- •Acetabular Dysplasia (LCEA < 20)
- •Tonnis 2+ OA
- •Previous ipsilateral hip surgery
- •Previous major hip trauma (hip fractures, hip dislocations)
- •Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders)
- •Unable to consent due to mental faculty
- •Pregnant women
- •Non-English speaking patients
- •Prisoners or other vulnerable populations
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
时间窗: Pre operative (Baseline), change from baseline PROMIS - PF at 3 months, change from baseline PROMIS - PF at 6 months, change from baseline PROMIS -PF at 1 year, and change from baseline PROMIS - PF at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's physical function. PROMIS - PF is scored from 14.7-75.6 with the higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)
时间窗: Pre operative (Baseline), change from baseline PROMIS - PI at 3 months, change from baseline PROMIS - PI at 6 months, change from baseline PROMIS -PI at 1 year, and change from baseline PROMIS - PI at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's pain interference. PROMIS - PI is scored from 38.7-83.8 with the lower scores being the best outcome.
Hip disability and Osteoarthritis Outcome Score (HOOS)
时间窗: Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year.
HOOS is a questionnaire constructed to assess patient-relevant outcomes in five separate sub-scales (pain, symptoms, activity of daily living, sport and recreation function and hip-related quality of life). HOOS is scored 0-100 with higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)
时间窗: Pre operative (Baseline), change from baseline PROMIS - M at 3 months, change from baseline PROMIS - M at 6 months, change from baseline PROMIS -M at 1 year, and change from baseline PROMIS - M at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's mobility. PROMIS - M is scored from 18.2-60.2 with the higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)
时间窗: Pre operative (Baseline), change from baseline PROMIS - A at 3 months, change from baseline PROMIS - A at 6 months, change from baseline PROMIS - A at 1 year, and change from baseline PROMIS - A at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's anxiety. PROMIS - A is scored from 32.9-84.9 with the lower scores being the best outcome.
Short Form Health Survey (SF-12)
时间窗: Pre operative (Baseline), change from baseline SF-12 at 3 months, change from baseline SF-12 at 6 months, change from baseline SF-12 at 1 year, and change from baseline SF-12 at 2 year
The SF-12 is a shortened, validated, patient-reported survey of patient health with questions pulled directly from the longer form SF-36. SF-12 is scored 0-100 with higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)
时间窗: Pre operative (Baseline), change from baseline PROMIS - D at 3 months, change from baseline PROMIS - D at 6 months, change from baseline PROMIS - D at 1 year, and change from baseline PROMIS - D at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's depression. PROMIS - D is scored from 34.2-84.4 with the lower scores being the best outcome.
次要结局
- Mobility, Stability, and Pain (MSP Question)(Pre operative (Baseline), 3 months, 6 month)
- International Hip Outcome Tool (iHot-12)(Pre operative (Baseline), change from baseline iHOT-12 at 3 months, change from baseline iHOT-12 at 6 months, change from baseline iHOT-12 at 1 year, and change from baseline iHOT-12 at 2 year)
- Modified Harris Hip Score (mHHS)(Pre operative (Baseline), change from baseline mHHS at 3 months, change from baseline mHHS at 6 months, change from baseline mHHS at 1 year, and change from baseline mHHS at 2 year)
- Brief Resilience Scale (BRS)(Pre operative (Baseline))
- University of California Los Angeles Activity Score (UCLA Score)(Pre operative (Baseline), change from baseline UCLA Score at 3 months, change from baseline UCLA Score at 6 months, change from baseline UCLA Score at 1 year, and change from baseline UCLA Score at 2 year)