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Orthotics

Vktory Carbon fiber insoles for Hallux Rigidus

N/A
Waitlist Available
Led By Gregory Waryasz, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at initial visit, 2 weeks, 6 weeks and 12 weeks
Awards & highlights

Summary

Hallux rigidus is a degenerative disease of the first metatarsophalangeal (MTP) joint which affect 2.5% 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 it's 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, i.e. 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

Eligible Conditions
  • Hallux Rigidus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at initial visit, 2 weeks, 6 weeks and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at initial visit, 2 weeks, 6 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline Compliance and activity Questionnaire at 2 weeks, 6 weeks, and 12 weeks
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Depression at 2 weeks, 6 weeks, and 12 weeks
Change from Baseline Patient Reported Outcomes Measured Institute System (PROMIS) Global Health at 2 weeks, 6 weeks, and 12 weeks
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Vktory Carbon fiber insolesActive Control1 Intervention
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, i.e. patients can use this insole in their own shoes, possibly leading to a higher patient compliance and, simultaneously, to better outcome
Group II: Morton's extension insolesActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,664 Total Patients Enrolled
VKTRY GearUNKNOWN
Gregory Waryasz, MDPrincipal InvestigatorMassachusetts General Hospital
~2 spots leftby Sep 2025