Back to resultsBeneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty
Primary Purpose
Weight Loss, Pain, Postoperative
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States Minor Outlying Islands
Study Type
Interventional
Intervention
Topamax
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experiment
Control
Arm Description
Topamax randomized group
Gabapentin randomized group
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
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.
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.
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.
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.
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
SF12 will be calculated after surgery
SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks
SF12 will be calculated after surgery
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
SF12 will be calculated after surgery
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week
SF12 will be calculated after surgery
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04613024
Brief Title
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty
Official Title
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment
Arm Type
Experimental
Arm Description
Topamax randomized group
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Gabapentin randomized group
Intervention Type
Drug
Intervention Name(s)
Topamax
Intervention Description
Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Control group will be prescribed gabapentin after surgery with follow up at regular interval
Primary Outcome Measure Information:
Title
Determine the reduction in Opioid Consumption
Description
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.
Time Frame
3 months
Title
Evaluate the Side Effect Profiles of Topiramate
Description
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Time Frame
3 months
Title
Evaluate the Side Effect Profiles of gabapentin
Description
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin
Description
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.
Time Frame
1 week
Title
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
Description
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.
Time Frame
2 week
Title
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Description
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.
Time Frame
6week
Title
Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Description
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.
Time Frame
3 months
Title
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Description
SF12 will be calculated after surgery
Time Frame
3 months
Title
SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks
Description
SF12 will be calculated after surgery
Time Frame
2 week
Title
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Description
SF12 will be calculated after surgery
Time Frame
6 week
Title
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week
Description
SF12 will be calculated after surgery
Time Frame
1 week
Title
WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Description
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
Time Frame
6 week
Title
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
Description
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
Time Frame
2 week
Title
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Description
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
Time Frame
3 months
Title
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Description
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
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derek Amanatullah, Md PhD
Phone
6507232257
Email
arprerna@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
Country
United States Minor Outlying Islands
12. IPD Sharing Statement
Learn more about this trial
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty
We'll reach out to this number within 24 hrs