Multi-Plane Hallux Valgus Correction With the Phantom® Nail

September 22, 2022 updated by: Paragon 28

Correction of Multi-Plane Hallux Valgus Deformity Using the Phantom® Intramedullary Nail

The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique.

The study hypothesis is that multi-planar correction can be achieved with the Phantom® Intramedullary Nail.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Each subject will undergo a Lapidus Arthrodesis combined with a supinating reduction technique.

The subjects will undergo 3 weight-bearing CBCT scans of their foot and ankle, one pre-arthrodesis, one two weeks post-arthrodesis, and one 12 weeks post-arthrodesis. These scans will be used to determine change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint, change in angular/positional alignment of the 1st TMT joint using various measurements (1-2 IMA, Meary's Angle, HVA, MAA, Sesamoid Position, and Sesamoid Frontal Plane Rotation), maintenance of correction of the 1st TMT joint, and union status.

The subjects will also complete three surveys, the Pain and Satisfaction Survey, the AOFAS Hallux MTP-IP Scale, and the FAOS Foot and Ankle Survey, at the Pre-Operative Visit, 2 Week Visit (post-op), 6 Week Visit (post-op), and 12 Week Visit (post-op). Furthermore, the subjects will be asked about their willingness to undergo the procedure again at the 12 Week Visit (post-op). All of these scores will be considered in the secondary objectives.

Aside from the study activities listed above, all procedures, visits, and instructions for the subject are to follow the standard of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Atlantis, Florida, United States, 33462
        • Orthopedic Center of Palm Beach County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adults age 18 and older with a hallux valgus deformity. The most common age demographic to have surgery for hallux valgus correction is age 50-59. Additionally, the prevalence of hallux valgus in females is greater than males, so a higher percentage of female subjects seeking treatment is likely to be expected.

Description

Inclusion Criteria:

  • The subject is at least 18 years of age at the time of screening.
  • The subject has been diagnosed with hallux valgus.
  • The subject has pain associated with hallux valgus.
  • The subject agrees to comply with the requirements of the study and complete the study measures.
  • The subject is willing and able to provide written informed consent.
  • The subject plans to undergo a Lapidus Arthrodesis procedure with a 3-Hole Phantom® Intramedullary Nail.

Exclusion Criteria:

  • The subject is pregnant.
  • The subject has had previous surgery for hallux valgus on operative side.
  • The subject will require a structural graft in the 1st TMT joint.
  • The unshod foot in question is greater than 28 cm in length.
  • The subject is not expected to complete the study according to the investigation plan.
  • The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
  • The subject is a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs, or anticipated to be non-compliant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All Study Participants
Phantom® Intramedullary Nail combined with a supinating reduction technique
Device: Intramedullary Nail
Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus
Other Names:
  • Phantom® Intramedullary Nail

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Frontal Plane Rotation
Time Frame: 12 weeks
Determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st tarsometatarsal joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1-2 Inter Metatarsal Angle
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in 1-2 Inter Metatarsal Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Meary's Angle
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in Meary's Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Hallux Valgus Angle
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in Hallux Valgus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Metatarsus Adductus Angle
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in Metatarsus Adductus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Sesamoid Position
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in sesamoid position before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Sesamoid Frontal Plane Rotation
Time Frame: Pre-op, 2 weeks, 12 weeks
Change in sesamoid frontal plane rotation before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Pre-op, 2 weeks, 12 weeks
Maintenance of Correction
Time Frame: Pre-op, 2 weeks, 12 weeks
Maintenance of lapidus arthrodesis correction via CBCT analysis
Pre-op, 2 weeks, 12 weeks
Union Status
Time Frame: 12 weeks
Union/delayed union status at 12 Week Visit
12 weeks
Clinical Complications
Time Frame: Pre-Op, 2 weeks, 6 weeks,12 weeks
Any lapidus arthrodesis related clinical complications
Pre-Op, 2 weeks, 6 weeks,12 weeks
Patient Current Level of Pain at Surgical Site
Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Pre-Op, 2 weeks, 6 weeks, 12 weeks
AOFAS
Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks

Change in AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale scores

AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale foot clinical score. Pain: 0-40 points Function: 0-45 points Alignment: 0-15 points Total Score (sum): 0-100 points (higher score indicates better outcomes)
Pre-Op, 2 weeks, 6 weeks, 12 weeks
FAOS
Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks

Change in FAOS Foot and Ankle Survey scores

Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

Subscales:

Pain Other Symptoms Functions in Daily Living (ADL) Function in sport and recreation Foot and ankle-related Quality of Life (QoL)
Pre-Op, 2 weeks, 6 weeks, 12 weeks
Patient Satisfaction with Procedure
Time Frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Patient reported satisfaction by check boxes (Likert Scale) from Pain and Satisfaction Survey
Pre-Op, 2 weeks, 6 weeks, 12 weeks
Willingness to Undergo Procedure Again
Time Frame: 12 weeks
Willingness to undergo procedure again (Yes/No)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paragon 28

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laura Brinker, DPM, Director of Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P30-SP-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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