ArthrodesisNCT04084262
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
An observational study of Arthrodesis and Bunion, run by Paragon 28 at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthrodesis, Bunion, Hallux Valgus
- What is being tested?
- Intramedullary Nail
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 9 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Center of Palm Beach County
Atlantis, Florida, 33462
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Being tested
- Intramedullary Nail
- Keywords
- bunion, supinating reduction, multi-plane, lapidus, arthrodesis, intramedullary nail, hallux valgus
- Medical subject headings
- Ankylosis, Bunion, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary NailDevice
Also called Phantom® Intramedullary Nail
Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Phantom® Intramedullary Nail combined with a supinating reduction technique Receives: Device: Intramedullary Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (14)
1-2 Inter Metatarsal Angle
Change in 1-2 Inter Metatarsal Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Meary's Angle
Change in Meary's Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Hallux Valgus Angle
Change in Hallux Valgus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Metatarsus Adductus Angle
Change in Metatarsus Adductus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Sesamoid Position
Change in sesamoid position before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Sesamoid Frontal Plane Rotation
Change in sesamoid frontal plane rotation before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Measured: Pre-op, 2 weeks, 12 weeks
Maintenance of Correction
Maintenance of lapidus arthrodesis correction via CBCT analysis
Measured: Pre-op, 2 weeks, 12 weeks
Union Status
Union/delayed union status at 12 Week Visit
Measured: 12 weeks
Clinical Complications
Any lapidus arthrodesis related clinical complications
Measured: Pre-Op, 2 weeks, 6 weeks,12 weeks
Patient Current Level of Pain at Surgical Site
Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks
AOFAS
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)
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks
FAOS
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)
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Patient Satisfaction with Procedure
Patient reported satisfaction by check boxes (Likert Scale) from Pain and Satisfaction Survey
Measured: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Willingness to Undergo Procedure Again
Willingness to undergo procedure again (Yes/No)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start7 Nov 2019
- Primary completion1 Apr 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragon 28
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Brinker, DPM, Study director, Director of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084262
- Sponsor's protocol ID
- P30-SP-0002
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2019
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Multi-Plane Hallux Valgus Deformity Using the Phantom® Intramedullary Nail
- ClinicalTrials.gov ID
- NCT04084262
- Acronym / sponsor ID
- P30-SP-0002
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Keywords
- bunion, supinating reduction, multi-plane, lapidus, arthrodesis, intramedullary nail, hallux valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Device: Intramedullary NailPhantom® Intramedullary Nail combined with a supinating reduction technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary NailAlso: Phantom® Intramedullary NailSubjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus | Device | All Study Participants |
Primary outcome
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.
14 secondary outcomes
1-2 Inter Metatarsal Angle
Time frame: Pre-op, 2 weeks, 12 weeks
Meary's Angle
Time frame: Pre-op, 2 weeks, 12 weeks
Hallux Valgus Angle
Time frame: Pre-op, 2 weeks, 12 weeks
Metatarsus Adductus Angle
Time frame: Pre-op, 2 weeks, 12 weeks
Sesamoid Position
Time frame: Pre-op, 2 weeks, 12 weeks
Sesamoid Frontal Plane Rotation
Time frame: Pre-op, 2 weeks, 12 weeks
Maintenance of Correction
Time frame: Pre-op, 2 weeks, 12 weeks
Union Status
Time frame: 12 weeks
Clinical Complications
Time frame: 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
AOFAS
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
FAOS
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Patient Satisfaction with Procedure
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Willingness to Undergo Procedure Again
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Brinker, DPM study director
Director of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrodesis and Bunion, run by Paragon 28 at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frontal Plane Rotation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.