Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery: 1. To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure. 2. To determine whether the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated study duration will be 5 years post index procedure.
Foot and Ankle Center of the Rockies
Greeley, Colorado, United States
RECRUITINGFoot and Ankle Center of Iowa
Ankeny, Iowa, United States
RECRUITINGCoastal Maine Foot and Ankle
Yarmouth, Maine, United States
RECRUITINGJCMG - Jefferson City Medical Group
Jefferson City, Missouri, United States
RECRUITINGDuke Orthopaedics Arringdon
Morrisville, North Carolina, United States
RECRUITINGOhio Foot and Ankle Center
Canton, Ohio, United States
RECRUITINGOhio Foot and Ankle Center
Stow, Ohio, United States
RECRUITINGGreater Pittsburgh Foot and Ankle Center
Wexford, Pennsylvania, United States
RECRUITINGFoot and Ankle Associates of North Texas - Keller
Keller, Texas, United States
RECRUITINGRadiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
Successful correction is defined as two of the following three criteria: measured IMA \<9.0°, HVA \<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \>15.0°.
Time frame: 24 Months
Radiographic Recurrence
Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA \>20°.
Time frame: 24 Months
Union vs non-Union
Evaluate clinical/radiographic healing (union vs non-union). Non-union is defined as pain and lucency at the 1st, 2nd, and/or 3rd TMT joint at 12 months post- Adductoplasty® Procedure and Lapiplasty® Procedure.
Time frame: 12 Months
Clinical Complications
Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.
Time frame: 60 Months
Weight-Bearing Recovery Time
Assessment of weight-bearing recovery time following the procedures. Weight-bearing will be measured in days and recorded based upon individual surgeon recovery protocol.
Time frame: 12 Months
Time to Weight-Bear in Boot
Time to start of weight-bearing in boot, in days.
Time frame: 6 Weeks
Time to Weight-Bear in Shoes
Time to start of weight-bearing in shoes, in days.
Time frame: 8 Weeks
Time to Return to Unrestricted Activity
Time to return to full unrestricted activity, in days.
Time frame: 6 weeks - 6 months, post Lapiplasty® Procedure
Change in Pain
Change in pain at the base of the big toe (bunion related), as well as the midfoot region for the operative foot only, assessed via the Visual Analog Scale (VAS) with 0-10 minimum and maximum values - with 0 being a better outcome and 10 being a worse outcome.
Time frame: 0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.
Change in Quality of Life
Change in Quality of Life, (PROMIS-29/PROMIS-25 and MOxFQ) defined as the total domain score measured.
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Range of Motion
Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion
Time frame: 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
Change in Osseous Foot Width
Change in osseous foot width - radiographically
Time frame: 12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit
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