Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
研究概览
简要总结
The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.
详细描述
Primary Objective and Outcome Measure:
- Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Secondary Objectives and Outcome Measures:
-
Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
-
Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically:
-
EQ5D: Eur-Quality of Life 5 dimension questionnaire
-
ODI: Oswestry Disability Index
-
Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the practices of Drs. Singh, Mallozzi, Moss
- •Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
- •Patients who agree to be a part of the study
- •Patients with lumbar disc degeneration
- •Patients between ages of 18 and 75
排除标准
- •Scoliosis >10°
- •Spondylolisthesis >Grade 1
- •Flatback deformity
- •Patients with insulin dependent diabetes
- •Patients with >3 levels of fusion
- •Alternative interbodies
- •Chronic oral steroid users
- •Patients with allergy/intolerance to depo-medrol or other steroids
- •Patients requiring bilateral transpsoas approaches
- •Patients with ipsilateral symptomatic hip pathology
- •Revision fusion procedures
- •Cases involving trauma, tumor, or infection
- •Patient's not capable of providing consent themselves
- •Non-fluent English speakers (for consenting reasons)
- •Patients who are lost to follow-up before the two year follow up period
研究组 & 干预措施
Control group (standard care)
1 cc gel foam powder mixed with thrombin
干预措施: Gel-Flow NT (Drug)
Test group (standard care + study intervention)
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
干预措施: Depo-Medrol (Drug)
Test group (standard care + study intervention)
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
干预措施: Gel-Flow NT (Drug)
结局指标
主要结局
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
时间窗: 12 weeks following surgery
Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?
次要结局
- Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)(2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years)
- Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Euro-Quality of Life 5 dimension questionnaire (EQ5D)(2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years)
- Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.(1 year and 2 years)
- Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.(6 months, 1 year, 2 years)
- Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index(2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years)
- Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.(6 months, 1 year, 2 years)
研究者
Hardeep Singh
Assistant Professor of Orthopedic Surgery
UConn Health