Early Weight-Bearing After Lapiplasty for Bunions

(ALIGN3D Trial)

Not currently recruiting at 6 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Treace Medical Concepts, Inc.

Must not be taking: Oral steroids, rheumatoid biologics, immunosuppressants

Disqualifiers: Diabetes, Peripheral neuropathy, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Lapiplasty® Procedure can help people with bunions (hallux valgus) and examines the effects of early walking post-surgery. Researchers aim to determine if this surgery effectively maintains toe bone alignment and impacts pain and quality of life. The trial seeks participants who need bunion surgery, have not undergone similar surgeries, and can adhere to instructions for early walking after the procedure. As an unphased trial, this study allows patients to contribute to innovative research and potentially enhance their post-surgery outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking oral steroids, rheumatoid biologics, or immunosuppressant drugs.

What prior data suggests that the Lapiplasty procedure is safe for early weight-bearing?

Studies have shown that the Lapiplasty procedure effectively corrects bunions, with 97.4% of patients achieving successful joint fusion, meaning their bones healed as planned. Additionally, 98.9% of patients maintained stable joints after the procedure.

However, some risks exist. Common issues include pain, affecting 41.9% of patients, and non-union, where bones do not join together, occurring in 18.2% of cases. Furthermore, 11.7% of patients experienced irritation from the hardware used in the procedure.

Overall, while many patients experience positive outcomes, awareness of these potential side effects is important. Consulting with a doctor is essential to determine if this procedure is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional bunion treatments that often involve lengthy recovery times and limited mobility post-surgery, Lapiplasty is unique because it allows for early weight-bearing. This innovative approach not only stabilizes the foot in three dimensions but also promotes faster recovery, potentially reducing downtime significantly. Researchers are excited about Lapiplasty because it aims to correct the root cause of bunions by realigning the bones, rather than just shaving off the protrusion, which could lead to more durable and satisfying outcomes for patients.

What evidence suggests that the Lapiplasty procedure is effective for correcting bunions?

Studies have shown that the Lapiplasty® Procedure effectively fixes bunions. Research indicates that patients experienced an 81% reduction in pain and an 89% improvement in their ability to walk and stand, with these benefits lasting at least four years. Additionally, patients could begin walking with some protection about 8 days after the procedure. X-ray evidence shows significant improvement in bunion correction, maintaining proper foot alignment. Overall, the data supports that Lapiplasty® provides long-term relief and improved function for those with bunions. ^{5 6 7 8 9}

Who Is on the Research Team?

Dane Wukich, MD

Principal Investigator

UTSW

Are You a Good Fit for This Trial?

This trial is for individuals aged 14-58 with mild to moderate bunions, who can undergo general anesthesia and are able to follow early weight-bearing instructions after surgery. They must not be pregnant or planning pregnancy soon, have closed growth plates in their bones, and be capable of filling out questionnaires.

Inclusion Criteria

I can fill out questionnaires by myself.

I can have the main treatment within 3 months and can go to all follow-up visits.

Willing and able to provide written informed consent

Exclusion Criteria

Patient is currently or has participated in a clinical study in the last 30 days prior to signing

Patient is actively involved with a workman's compensation case or is currently involved in litigation

I have flatfoot with symptoms or severe flatfoot without symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo the Lapiplasty® Procedure and initial recovery, including fitting with a CAM boot and instructions for protected weight-bearing

0-3 weeks

1 visit (in-person)

Weight-Bearing Transition

Participants transition from CAM boot to shoe and begin low impact activities as tolerated

6 weeks to 4 months

2 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and radiographic outcomes after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Lapiplasty

Trial Overview The Lapiplasty Procedure is being tested for its effectiveness in correcting bunions (hallux valgus) on three planes, assessing the impact of early weight-bearing on surgical outcomes like bone healing and alignment maintenance, as well as evaluating quality of life and pain reduction post-surgery.

How Is the Trial Designed?

Group I: Lapiplasty Experimental Treatment 1 Intervention

All study participants receiving Lapiplasty procedure

Who Is Running the Clinical Trial?

Treace Medical Concepts, Inc.

Lead Sponsor

Trials

4

Recruited

590+

Citations

1. investors.treace.com investors.treace.com/news-releases/news-release-details/treace-announces-peer-reviewed-publication-four-year-results

Treace Announces Peer-Reviewed Publication of Four-Year ... “These interim results from the ALIGN3D™ study showed consistent, positive radiographic and patient-reported outcomes maintained at four years,” ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03740282

Early Weight-Bearing After the Lapiplasty Procedure The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery:.

3. investors.treace.com investors.treace.com/news-releases/news-release-details/treace-announces-clinical-study-data-demonstrating-positive

Treace Announces Clinical Study Data Demonstrating ... Early return to protected weight bearing at an average 8.4 days;; Low ... The primary effectiveness endpoint is radiographic recurrence of the ...

4. lapiplasty.com lapiplasty.com/surgeons/journal-publications/

Journal Publications | Treace Medical Concepts, Inc. Early return to weight bearing in a walking boot at an average 7.8 days;; Significant improvement in radiographic measures of 3-dimensional bunion correction ...

5. stocktitan.net stocktitan.net/news/TMCI/treace-announces-peer-reviewed-publication-of-four-year-results-of-mye1ctpv3xl4.html

4-Year Study Shows 99% Success Rate for Lapiplasty ... Patient outcomes showed significant improvements, with an 81% reduction in pain and 89% improvement in walking/standing capabilities through the ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667396723000824

Adverse events related to triplanar 1st tarsometatarsal joint ... The most frequently encountered patient problems were pain in 41.9%, non-union in 18.2%, and hardware-related irritation in 11.7%.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11292705/

Comparison of Minimally Invasive Chevron Akin and Open ... MIS and open surgical techniques appear to be safe and effective in correcting hallux valgus in older patients.

8. ryortho.com ryortho.com/2019/05/bunion-correction-with-lapiplasty-data-released/

Bunion Correction With Lapiplasty Data Released 97.4% of the patients experienced a successful fusion of the joint and for 98.9%, stability of the joint remained solid throughout the study.

9. lapiplasty.com lapiplasty.com/patient-risk-information/

Patient Risk Information | Lapiplasty® 3D Bunion ... Risks of the Procedures include but are not limited to the following: Delayed/loss of correction or loss of anatomic position with nonunion or malunion.