Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833608
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2021-03-31
Brief Title:
Managing Pain in Patients With MTP Arthritis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Using Flexible Carbon Fiber Insoles for 1st Metatarsophalangeal Arthritis Lead to Pain Reduction and High Compliance Rate A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hallux rigidus is a degenerative disease of the first metatarsophalangeal MTP joint which affect 25 of people over the age of 50 As the arthritis progresses patients pain levels increase and range of motion decreases Non-operative management includes the use of NSAIDS intra-articular injections shoe modification activity modifications and physical therapy Oral NSAID have been used extensively to reduce swelling and pain but have been found unsatisfactory in providing pain relief Injections have been shown relieve pain in patients with grade 1 MTP arthritis Shoe modifications and orthotics can modify the biomechanics of the MTP joint and thereby alleviate pain Based on expert opinions it seems the Morton extensions may alleviate pain but are also poorly tolerated by patients due to its uncomfortable shape coincidently leading to a low patient compliance rate
VKTRY insoles were initially designed to increase ground force leading to a harder push off for faster running or higher jumping To enable energy return the insole needed to be extremely rigid and therefore consists out of a full-length Carbon-Fiber base Unexpectedly the Carbon fiber base makes this a highly rigid construct which will likely benefit those patients with MTP arthritis as it will take away much movement of the MTP joint without having an uncomfortable shape ie patients can use this insole in their own shoes possibly leading to a higher patient compliance and simultaneously to better outcome Even though this insole is being widely used by athletes no one has explored its role for treating patients with MTP joint arthritis Therefore the aim of this study is to compare the VKTRY insole to the current Morton extension insoles in a blinded randomized controlled trial
VKTRY insoles were initially designed to increase ground force leading to a harder push off for faster running or higher jumping To enable energy return the insole needed to be extremely rigid and therefore consists out of a full-length Carbon-Fiber base Unexpectedly the Carbon fiber base makes this a highly rigid construct which will likely benefit those patients with MTP arthritis as it will take away much movement of the MTP joint without having an uncomfortable shape ie patients can use this insole in their own shoes possibly leading to a higher patient compliance and simultaneously to better outcome Even though this insole is being widely used by athletes no one has explored its role for treating patients with MTP joint arthritis Therefore the aim of this study is to compare the VKTRY insole to the current Morton extension insoles in a blinded randomized controlled trial
Detailed Description:
Subject Enrollment
Patients were introduced to the study by Foot and Ankle orthopaedic surgeons if they were identified as having hallux rigidis If the patient agreed an authorized member of the study staff went through the study in detail and addressed any questions the patients had If the patient was willing to participate informed consent was obtained We emphasized that not participating in the study will not affect their care now or in the future
Once informed consent was obtained the patient was randomized into one of two groups
Morton Extensions along with current pain management protocol
VKTRY insoles along with the current pain management protocol
Explanatory variables gathered
1 Basic patient characteristics
2 Range of motion at 1st MTP joint
3 Hallux Rigidus severity grading
Patients were evaluated at the initial appointment 2 weeks 6 weeks and 12 weeks following their initial appointment The surveys were given to the patients during each evaluation time point
Sample Size Calculation
Based on power analysis to detect a minimal clinically important difference of 106 - 46 SD points in the PROMIS pain intensity score between patients using the Vktory carbon fiber insole and patients using Mortons extension insole with an overall two-tailed Type-1 rate of 5 80 statistical power and accounting for a 30 lost to follow up we needed 14 patients in total
Patients were introduced to the study by Foot and Ankle orthopaedic surgeons if they were identified as having hallux rigidis If the patient agreed an authorized member of the study staff went through the study in detail and addressed any questions the patients had If the patient was willing to participate informed consent was obtained We emphasized that not participating in the study will not affect their care now or in the future
Once informed consent was obtained the patient was randomized into one of two groups
Morton Extensions along with current pain management protocol
VKTRY insoles along with the current pain management protocol
Explanatory variables gathered
1 Basic patient characteristics
2 Range of motion at 1st MTP joint
3 Hallux Rigidus severity grading
Patients were evaluated at the initial appointment 2 weeks 6 weeks and 12 weeks following their initial appointment The surveys were given to the patients during each evaluation time point
Sample Size Calculation
Based on power analysis to detect a minimal clinically important difference of 106 - 46 SD points in the PROMIS pain intensity score between patients using the Vktory carbon fiber insole and patients using Mortons extension insole with an overall two-tailed Type-1 rate of 5 80 statistical power and accounting for a 30 lost to follow up we needed 14 patients in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None