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Managing Pain in Patients With MTP Arthritis

NCT04833608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-04-06

No results posted yet for this study

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

Conditions

  • Hallux Rigidus

Interventions

DEVICE

Vktory insoles

Patients were randomized into either the Carbon fiber insole group or Morton's extension group.

DEVICE

Morton's extension insoles

Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group.

Sponsors & Collaborators

  • VKTRY Gear

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Gregory Waryasz, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-02-27
Completion
2020-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04833608 on ClinicalTrials.gov