Phase
Condition
Bunion
Treatment
Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
Clinical Study ID
Ages 14-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and females ≥14 years old at the time of consent
Closed physeal plates at the time of consent
Intermetatarsal angle is ≥8.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA)
Hallux valgus angle is ≥12.0˚
Metatarsus adductus angle based on Sgarlatos method ≥15°
Willing and able to adhere to post-op care instructions
Capable of completing self-administered questionnaires
Acceptable surgical candidate, including use of general anesthesia
Female patients must be of non-childbearing potential or have a negative pregnancytest in accordance with hospital standards prior to the Index Procedure
Willing and able to schedule index procedure within 3 months of consent and able toreturn for scheduled follow-up visits
Willing and able to provide written informed consent
Patient agrees to refrain from any reconstructive procedures on contralateral footfor minimum of 6 months post index procedure
Exclusion
Exclusion Criteria:
Previous surgery for hallux valgus on operative side
Previous surgeries on operative foot involving fusion of foot or ankle joints (otherthan hammertoe, lesser toes/digits, or posterior muscle lengthening)
Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rdtarsometatarsal joints
Moderate-severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
Any deformity of the hindfoot or midfoot that represents a pathological conditionthat may affect the outcome of the tarsometatarsal realignment, or a condition thatrequires concomitant surgical correction
BMI >40 kg/m²
Current nicotine user in any form including vaping, smoking, oral ingestion or useof nicotine patch
Current clinical diagnosis of diabetes or currently taking medication for treatmentof diabetes
Current clinical diagnosis of peripheral neuropathy
Current clinical diagnosis of fibromyalgia
Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex SympatheticDystrophy (CRPS/RSD)
Current uncontrolled hypothyroidism
Current clinical diagnosis of chronic dependent edema
Previously sensitized to titanium
Currently taking oral steroids or rheumatoid biologics
Currently taking immunosuppressant drugs
Insufficient quantity or quality of bone to permit stabilization, conditions thatinhibit healing (not including pathological fractures) and conditions causing poorblood supply such as peripheral vascular disease
Active, suspected, or latent infection in the affected area
Use of synthetic or allogenic bone graft substitutes
Use of non-Treace products for Index Procedure
Additional bone procedure needed during the index procedure to complete correction (additional metatarsal or tarsal bone osteotomy or fusion, first MTP fusion,calcaneal osteotomy, traditional medial eminence resection);
Scheduled to undergo a same-day bilateral procedure
Patient has previously been enrolled into this study for a contralateral procedure
Scheduled for any concomitant procedure that would alter patient's ability toweight-bear post-procedure
Patient is actively involved with a workman's compensation case or is currentlyinvolved in litigation
Patient is currently in, or has participated in, a clinical study in the last 30days prior to signing informed consent or is considering participation in anotherresearch protocol during this study. Exceptions to this include survey clinicalstudies with no treatment or if subject is greater than 12 months post procedure ineither the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE
Patient has a condition or finding that, in the opinion of the Investigator, mayjeopardize the patient's well-being, the soundness of this clinical study, or couldinterfere with provision of informed consent, completion of tests, therapy, orfollow-up
Study Design
Study Description
Connect with a study center
Foot and Ankle Center of the Rockies
Greeley, Colorado 80634
United StatesActive - Recruiting
Foot and Ankle Center of Iowa
Ankeny, Iowa 50023
United StatesActive - Recruiting
Coastal Maine Foot and Ankle
Yarmouth, Maine 04096
United StatesActive - Recruiting
JCMG - Jefferson City Medical Group
Jefferson City, Missouri 65019
United StatesActive - Recruiting
Duke Orthopaedics Arringdon
Morrisville, North Carolina 27560
United StatesActive - Recruiting
Ohio Foot and Ankle Center
Canton, Ohio 44708
United StatesActive - Recruiting
Ohio Foot and Ankle Center
Stow, Ohio 44224
United StatesActive - Recruiting
Greater Pittsburgh Foot and Ankle Center
Wexford, Pennsylvania 15090
United StatesActive - Recruiting
Foot and Ankle Associates of North Texas - Keller
Keller, Texas 76248
United StatesActive - Recruiting
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