Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery. Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery: 1. To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. 2. To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. 3. To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. 4. To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated subject duration will be 2 years post index procedure.
DOC - Decatur Orthopaedic Clinic
Decatur, Alabama, United States
DOC - Decatur Orthopaedic Clinic
Hartselle, Alabama, United States
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, United States
Radiographic Recurrence
To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure
Time frame: 24 months
Radiographic Angular/Positional Alignment
Change in radiographic angular/positional alignment before/after the Lapiplasty® Procedure
Time frame: pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Radiographic Healing
Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint
Time frame: 12 months post Lapiplasty® Procedure
Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data
Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data
Time frame: 24 months post Lapiplasty® Procedure
Time to start weight-bearing in a boot
Time to start weight-bearing in a boot
Time frame: 0-3 weeks, post Lapiplasty® Procedure
Time to start weight-bearing in a shoe
Time to start weight-bearing in a shoe
Time frame: 6 weeks, post Lapiplasty® Procedure
Time to return to full unrestricted activity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orlando Foot and Ankle Clinic - Waterford Lakes Office
Orlando, Florida, United States
JCMG - Podiatry
Jefferson City, Missouri, United States
Desert Orthopaedic Center
Las Vegas, Nevada, United States
University of Pennsylvania / Penn Medicine
Philadelphia, Pennsylvania, United States
Stonebriar Foot and Ankle
Frisco, Texas, United States
Foot & Ankle Associates of North Texas - Keller
Keller, Texas, United States
Sports Medicine Associates of San Antonio
San Antonio, Texas, United States
Time to return to full unrestricted activity
Time frame: 6 weeks - 6 months, post Lapiplasty® Procedure
Change in Pain
Change in pain assess via Visual Analog Scale (VAS)
Time frame: 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Quality of Life
Change in quality of life via PROMIS-29, PROMIS-25, MOxFQ
Time frame: 6 months, 12 months, 24 months post Lapiplasty® Procedure
Change in Range of Motion
1st MTP dorsiflexion and plantarflexion
Time frame: 12 months, 24 months post Lapiplasty® Procedure
Change in Radiographic Foot Length
Change in radiographic foot length compared to baseline visit
Time frame: 12 months post Lapiplasty® Procedure
Change in Radiographic Foot Width
Change in radiographic foot width compared to baseline visit
Time frame: 12 months post Lapiplasty® Procedure
Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)
Change in swelling as compared to 0-2 week visit
Time frame: 6 weeks and 4 months post Lapiplasty® Procedure
Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)
Change in scar quality in comparison to baseline visit
Time frame: 4 months, 6 months, and 12 months post Lapiplasty® Procedure