NCT04084262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.4 years

First QC Date

September 6, 2019

Last Update Submit

September 22, 2022

Conditions

ArthrodesisBunionHallux Valgus

Keywords

bunionsupinating reductionmulti-planelapidusarthrodesisintramedullary nailhallux valgus

Outcome Measures

Primary Outcomes (1)

  • Change in Frontal Plane Rotation

    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 Outcomes (14)

  • 1-2 Inter Metatarsal Angle

    Pre-op, 2 weeks, 12 weeks

  • Meary's Angle

    Pre-op, 2 weeks, 12 weeks

  • Hallux Valgus Angle

    Pre-op, 2 weeks, 12 weeks

  • Metatarsus Adductus Angle

    Pre-op, 2 weeks, 12 weeks

  • Sesamoid Position

    Pre-op, 2 weeks, 12 weeks

  • +9 more secondary outcomes

Study Arms (1)

All Study Participants

Phantom® Intramedullary Nail combined with a supinating reduction technique

Device: Intramedullary Nail

Interventions

Intramedullary NailDEVICE

Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus

Also known as: Phantom® Intramedullary Nail
All Study Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Center of Palm Beach County

Atlantis, Florida, 33462, United States

Location

MeSH Terms

Conditions

AnkylosisBunionHallux Valgus

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesFoot Deformities, AcquiredFoot Deformities

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Laura Brinker, DPM

    Director of Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

November 7, 2019

Primary Completion

April 1, 2022

Study Completion

May 9, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)