Is NCT05587569 recruiting in Keller, TX?

Yes, NCT05587569 is currently recruiting participants at its Keller, TX location. This metatarsus adductus clinical trial is actively enrolling qualified participants.

How do I join the metatarsus adductus clinical trial in Keller?

To join this clinical trial in Keller, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Keller clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metatarsus Adductus Clinical Trial in Keller, TX

About This Metatarsus Adductus Study in Keller

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.

Sponsor: Treace Medical Concepts, Inc.

Who Can Participate

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 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

Exclusion Criteria

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 \[first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)\];

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 include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE

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, completion of tests, therapy, or follow-up

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Keller?

Yes, this clinical trial (NCT05587569) has an active research site in Keller, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metatarsus Adductus Treatment Options in Keller, TX

If you're searching for metatarsus adductus treatment options in Keller, TX, this clinical trial (NCT05587569) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Keller research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metatarsus adductus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metatarsus adductus clinical trials near you to find additional studies recruiting in your area.

Metatarsus Adductus Clinical Trial in Keller, TX

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