NCT03740282

Early Weight-Bearing After the Lapiplasty Procedure

Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesIs With Early WeiGht-BeariNg After Lapiplasty ProcDure (ALIGN3D)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Treace Medical Concepts, Inc. · Industry
• Sex: All
• Age: 14 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the following outcomes of the Lapiplasty® Procedure for patients in need of hallux valgus surgery: * The study will determine the radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure. * The study will determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes. * The study will assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction. * The study will evaluate the quality of life and pain scores following the Lapiplasty® Procedure.

Detailed description

Each subject will undergo the Lapiplasty® Procedure. The key surgical steps of the Lapiplasty® Procedure are releasing the 1st TMT joint, anatomical correction of the 3-plane deformity, bone preparation using the Lapiplasty® Cut Guide , provisional fixation and multiplanar permanent fixation with the BIPLANAR™ Plate. It is common for people who undergo a Lapidus Arthrodesis to be non-weight-bearing for 6-8 weeks following the surgical procedure. This time allows the bones to properly fuse together. During this 6-8 week period, people can be limited in the typical day-to-day activities they participate in, such as walking, shopping and working. The Lapiplasty® System Implants may allow subjects to bear weight earlier than traditional procedures without negatively effecting healing/union of the joint. By allowing people to bear weight earlier than traditional methods, it is possible that people will have the opportunity to resume typical day-to-day activities faster than usual. This study will investigate the Lapiplasty® Procedure and the Lapiplasty® System Implants with early weight-bearing. The study preference is that subject will be placed in a walking CAM boot and allowed to start protected weight bearing no later than 3 weeks after surgery. Subject can begin protected bearing weight in a CAM boot as early as the day of surgery. Subject will return to weight-bearing in shoe (running or another athletic shoe) and full unrestricted activity as directed by the physician based on the clinical stability and subject ability to safely begin weight-bearing and unrestricted activities. Recommended Approach for Post-Operative Care and Weight-Bearing Instructions * Subject may be either bandaged, put in splint/cast or put in CAM boot at the time of surgery. If subject is fitted with CAM boot at discharge, the patient should be provided instructions on how to begin protected weight-bearing. * Subject is instructed to remain off the operative foot as much as possible for the first few days post-op. This is to limit bleeding and swelling and to allow soft tissues to recover. * Subject may leave the surgery facility with crutches, walker, rolling knee scooter or wheelchair. * At the first post-op visit (0-3 weeks), bandages are removed, and the subject can be allowed to shower. Subject may wear an athletic sock. No bandages or splints are needed. The subject should be reminded of post-op care of the foot/surgical site. * At the first post-op visit (0-3 weeks), the subject is fitted with a CAM boot (if the subject was not fitted for a CAM boot at discharge). Subject should be provided with instructions on how to begin protected weight-bearing in the CAM boot and acceptable activities: * Patient is instructed to put weight on foot as tolerated in the restrictive boot. * Patient is instructed not to roll forward onto the big toe and should remain on flat foot. * Patient is instructed to remove the CAM boot multiple times daily and perform range of motion exercises for ankle and foot. * At the 6 week post-op visit, if the subject is clinically stable, subject can transition from the boot to a shoe (running or another athletic shoe). The transition from boot to shoe may occur over a period of days/weeks, depending on subject healing and tolerance. Subject is instructed that they can walk normally but are not to stand on toes, run, jump or do any other high impact activity * At the 4 month post-op visit, subject is allowed to begin low impact exercise if they are clinically stable.

Conditions

• Hallux Valgus
• Bunion

Interventions

Type	Name	Description
DEVICE	Lapiplasty	Patients 14 years through 58 years with symptomatic hallux valgus who are treated with the Lapiplasty System will begin weight-bearing by 3 weeks and follow a defined post-operative protocol.

Timeline

• Start date: 2018-11-06
• Primary completion: 2023-05-01
• Completion: 2026-05-31
• First posted: 2018-11-14
• Last updated: 2026-04-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study