Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change of pre-operative BMI
研究概览
简要总结
In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a BMI threshold <40 kg/m2 required for surgical eligibility, and postoperative outcomes versus SOC.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet eligibility criteria will be randomized into one of two groups: Standard of Care or the POPOP (20Lighter).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the interventions, masking or blinded participation is not possible.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at the University of Arkansas for Medical Sciences (Jeffrey Stambough, Dr. C. Lowry Barnes, Dr. Simon Mears, and Dr. Benjamin Stronach)
- •BMI between 41.00-48.00 kg/m2 at time of enrollment
- •Over the age of 18 years
- •Would consider undergoing a total joint arthroplasty if eligible
- •Owns a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection
- •Willing to comply with the requirements of the study and provide informed consent prior to enrollment.
排除标准
- •Patients with a BMI less than 41.00 or greater than 48.00
- •Pregnancy
- •Breastfeeding
- •History of a major organ transplant or other health issue requiring immunosuppressant drugs
- •Strict vegetarian diet
- •Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression
- •Patients scheduled for, or those who have previously undergone, bariatric surgery
- •Patients unable to understand and speak English
- •Patients requiring a revision or bilateral TJA
- •Patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access
- •Incarceration
研究组 & 干预措施
Standard of Care
The first arm consists of UAMS standard of care (SOC), including providing a brochure with information (contact information, brief educational information) for the patient to consult with a nutritionist to help with self-directed weight loss.
干预措施: SOC (standard of care) (Other)
Intervention (POPOP)
The second arm is a specified 2-month POPOP focused on weight loss administered by the external partner, 20Lighter. The program includes customized meal plans; vitamin, mineral and nutritional supplementation; and daily engagement via a smartphone app with a 20Lighter health care provider. Video conferencing appointments will occur approximately every 3 weeks. The program does not require any exercise or physical engagement but does necessitate that patients have a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection. During the first 40 days the customized meal plans are adhered to, then from days 41-60 patients will transition back to a normal dietary lifestyle via a customized plan based on considerations including, food preferences, physical engagement and height. Patients who achieve a BMI below 40.0 before the end of the 60 day program may be seen sooner than 90d for follow-up appointment in the UAMS clinic.
干预措施: POPOP (preoperative patient optimization program) (Other)
结局指标
主要结局
Change of pre-operative BMI
时间窗: Approximately 70-110 days from study enrollment
Assessment of mean change in BMI (Body Mass Index, kg/m2) between the date of enrollment to follow-up visit to occur between days 70-110
次要结局
- Pre-operative health & nutritional status as assessed by change of red blood cell count(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of albumin(Approximately 70-110 days from study enrollment)
- Change of pre-operative PROMs (Hip Replacement)(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of white blood cell count(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)(Approximately 70-110 days from study enrollment)
- Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of platelet count(Approximately 70-110 days from study enrollment)
- Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)(Approximately 70-110 days from study enrollment)
- Change of pre-operative health & nutritional status as assessed by Creatinine(Approximately 70-110 days from study enrollment)
- Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values(Approximately 70-110 days from study enrollment)
- Change of pre-operative PROMs (Knee Replacement)(Approximately 70-110 days from study enrollment)
- Change of pre-operative PROMIS Pain Interference(Approximately 70-110 days from study enrollment)
- Change of pre-operative PROMIS Physical Function(Approximately 70-110 days from study enrollment)