Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery

Detailed Description
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Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.

Official Title
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Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction

Conditions
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Weight Loss, Pain, Postoperative

Intervention / Treatment
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* Drug: Topamax
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI >30 and <40 kg/m2, or >40 kg/m2 Patients refusing bariatric surgery or having had prior bariatric surgery Exclusion Criteria Patients will be ineligible to participate if they have any of the following: known topiramate or gabapentin allergy history of seizure disorder chronic opiate use pre-operatively history of nephrolithiasis history of acute angle closure glaucoma recurrent major depression presence or history of suicidal behavior or ideation with intent to act current substantial depressive symptoms (Patient Health Questionnaire total score >10), pregnancy child-bearing potential and not on contraception age <18 years major neurocognitive disorder metabolic acidosis incarcerated status bilateral surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment<br>Topamax randomized group | Drug: Topamax<br>* Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval<br>|
| Active Comparator: Control<br>Gabapentin randomized group | Drug: Gabapentin<br>* Control group will be prescribed gabapentin after surgery with follow up at regular interval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the reduction in Opioid Consumption | Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control. | 3 months | 
| Evaluate the Side Effect Profiles of Topiramate | Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs | 3 months | 
| Evaluate the Side Effect Profiles of gabapentin | Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin | Harris hip score will be calculated after randomization at the pre-operative visit. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 1 week | 
| Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks | Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 2 week | 
| Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks | Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 6week | 
| Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months | Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | 3 months | 
| SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months | SF12 will be calculated after surgery | 3 months | 
| SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks | SF12 will be calculated after surgery | 2 week | 
| SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks | SF12 will be calculated after surgery | 6 week | 
| SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week | SF12 will be calculated after surgery | 1 week | 
| WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks | WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores | 6 week | 
| WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks | WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores | 2 week | 
| WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months | WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores | 3 months | 
| WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months | WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores | 1 week |