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NCT04833608 · ClinicalTrials.gov registry record · NA
Managing Pain in Patients With MTP Arthritis
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04833608: Completed NA study, sponsored by Massachusetts General Hospital.
NCT04833608 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04833608, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
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
Interventions
- DEVICE Vktory insoles
- DEVICE Morton's extension insoles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2020-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04833608
The ClinicalTrials.gov registry entry for NCT04833608 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vktory insoles is the first listed.
NCT04833608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04833608 about?
NCT04833608 is a clinical study titled "Managing Pain in Patients With MTP Arthritis". 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 injecti...
What is the current status of trial NCT04833608?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-04-30. Estimated completion is 2020-05-31.
What interventions are being tested in trial NCT04833608?
The interventions under investigation include: Vktory insoles (DEVICE), Morton's extension insoles (DEVICE).
Who is sponsoring clinical trial NCT04833608?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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