Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084262
• Other study ID #: P30-SP-0002
• Status: Completed
• Start date: November 7, 2019
• Est. completion date: May 9, 2022

Study information

• Verified date: September 2022
• Source: Paragon 28
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 9, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthrodesis
• Bunion
• Hallux Valgus

Intervention

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

Locations

Country	Name	City	State
United States	Orthopedic Center of Palm Beach County	Atlantis	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Paragon 28

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Pre-op, 2 weeks, 12 weeks
Secondary	Meary's Angle	Change in Meary's Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Secondary	Hallux Valgus Angle	Change in Hallux Valgus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Secondary	Metatarsus Adductus Angle	Change in Metatarsus Adductus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Secondary	Sesamoid Position	Change in sesamoid position before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Secondary	Sesamoid Frontal Plane Rotation	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
Secondary	Maintenance of Correction	Maintenance of lapidus arthrodesis correction via CBCT analysis	Pre-op, 2 weeks, 12 weeks
Secondary	Union Status	Union/delayed union status at 12 Week Visit	12 weeks
Secondary	Clinical Complications	Any lapidus arthrodesis related clinical complications	Pre-Op, 2 weeks, 6 weeks,12 weeks
Secondary	Patient Current Level of Pain at Surgical Site	Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Secondary	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)	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Secondary	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)	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Secondary	Patient Satisfaction with Procedure	Patient reported satisfaction by check boxes (Likert Scale) from Pain and Satisfaction Survey	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Secondary	Willingness to Undergo Procedure Again	Willingness to undergo procedure again (Yes/No)	12 weeks