BridgeMD
New treatment option for Metatarsus Adductus
Official title Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
ClinicalTrials.gov ID: NCT05587569
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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°
You likely can't join if
- Previous surgery for hallux valgus on operative side
- Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle...
- Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
- Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
- Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or...
- BMI \>40 kg/m²
See the full eligibility 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 pregnancy test in accordance with hospital standards prior to the Index Procedure
- Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits
- Willing and able to provide written informed consent
- Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure
- Previous surgery for hallux valgus on operative side
- Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
- Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
- Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
- Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
- BMI \>40 kg/m²
- Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
- Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
- Current clinical diagnosis of peripheral neuropathy
- Current clinical diagnosis of fibromyalgia
- Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (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 that inhibit healing (not including pathological fractures) and conditions causing poor blood 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 [first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion...
- 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 to weight-bear post-procedure
- Patient is actively involved with a workman's compensation case or is currently involved in litigation
- Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this...
- Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent...
The study team makes the final eligibility decision.
Where it's taking place
- Greeley, Colorado, United States
- Ankeny, Iowa, United States
- Yarmouth, Maine, United States
- Jefferson City, Missouri, United States
- Morrisville, North Carolina, United States
- Canton, Ohio, United States
- Stow, Ohio, United States
- Wexford, Pennsylvania, United States
- Keller, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greeley, Colorado, United States; Ankeny, Iowa, United States; Yarmouth, Maine, United States; Jefferson City, Missouri, United States; Morrisville, North Carolina, United States; Canton, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.