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| Name | Class |
|---|---|
| Society for Minimally Invasive Spine Surgery | OTHER |
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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.
Primary Objective and Outcome Measure:
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:
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.
Ancillary Objectives and Outcome Measures:
Groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (standard care) | Placebo Comparator | 1 cc gel foam powder mixed with thrombin |
|
| Test group (standard care + study intervention) | Experimental | 1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depo-Medrol | Drug | steroid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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"? | 2-3 weeks following surgery |
| 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. | 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"? | 6 weeks following surgery |
| 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. | 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"? | 12 weeks following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Thigh numbness - binary: yes/no | 6 months, 1 year, 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hardeep Singh, MD | Contact | 860-679-6883 | uconnorthopaedics@uchc.edu | |
| Study Coordinator | Contact | 860-679-6883 | uconnorthopaedics@uchc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hardeep Singh, M.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Recruiting | Farmington | Connecticut | 06030 | United States |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D010149 | Pain, Postoperative |
| D010292 | Paresthesia |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Gel-Flow NT |
| Drug |
hemostatic agent |
|
Hip flexion strength measured via graded exam: the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation
|
| 6 months, 1 year, 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) | The Euro-Quality of Life 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems." | 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: Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). | 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: Sciatica Bothersomeness Index | Sciatica Bothersomeness index includes self-reported ratings of symptom intensity of:
Each symptom item is rated on a scale from 0 to 6, with 0 being not bothersome, 3 somewhat bothersome and 6 extremely bothersome. | 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. | Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion) | 1 year and 2 years |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009468 | Neuromuscular Diseases |
| D059352 | Musculoskeletal Pain |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |