Early Weight-Bearing After the Lapiplasty Procedure (ALIGN3D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03740282|
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : March 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus Bunion||Device: Lapiplasty||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesIs With Early WeiGht-BeariNg After Lapiplasty ProcDure (ALIGN3D)|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2024|
All study participants receiving Lapiplasty procedure
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.
- Radiographic recurrence of hallux valgus [ Time Frame: 24 Months ]Defined as IMA ≥ 12, HVA ≥ 20 and TSP as ≥ 4 at 24 Months post Lapiplasty Procedure
- Change in radiographic angular/positional alignment before and after the Lapiplasty Procedure [ Time Frame: Pre-operatively, 6 Weeks, 4 Months, 6 Months, 12 Months, 24 Months, 36 Month, 48 Months, 60 Months ]Intermetatarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial Sesamoid Position (TSP)
- Clinical/radiographic healing [ Time Frame: 12 Months ]Evaluate clinical/radiographic healing (union vs non-union). Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint at 12 Months post-Lapiplasty Procedure
- Clinical complications [ Time Frame: 24 Months ]Complications due to the Lapiplasty procedure device or post-operative protocol or health conditions that could affect other health outcomes
- Time to start of weight-bearing in boot [ Time Frame: 0-3 Weeks ]The time needed for a study subject to begin bearing weight in a boot after the Lapiplasty Procedure
- Time to start of weight-bearing in shoes [ Time Frame: 0-12 Weeks ]The time needed for a study subject to begin bearing weight in a shoe after the Lapiplasty Procedure
- Time to return to full unrestricted activity [ Time Frame: 6 Weeks to 12 Months ]The time needed for a study subject to return to full unrestricted activity after the Lapiplasty Procedure
- Change in Visual Analog Scale (VAS) Pain Score [ Time Frame: Pre-operatively, 6 Weeks, 4 Months, 6 Months, 12 Months, 24 Months, 36 Month, 48 Months, 60 Months ]Patient reported foot pain intensity/0 (no pain) - 10 (worst possible pain)
- Change in PROMIS-29 score across multiple time-points [ Time Frame: Pre-operatively, 6 Months, 12 Months, 24 Months ]Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.1)/lowest possible score 29 - highest possible score 145. High scores mean more of the concept being measured.
- Change in PROMIS-25 score across multiple time-points [ Time Frame: Pre-operatively, 6 Months, 12 Months, 24 Months ]Patient-Reported Outcomes Measurement Information System (PROMIS-25 Profile v2.0)/lowest possible score 25 - highest possible score 135. High scores mean more of the concept being measured.
- Change in MOxFQ Foot Problems score across multiple time-points [ Time Frame: Pre-operatively, 6 Months, 12 Months, 24 Months ]Manchester-Oxford Foot Questionnaire (MOxFQ)/0 (minimum raw score) - 64 (maximum raw score). Raw score is converted to a metric of 0 - 100 with higher score representing greater severity
- Change in Range of Motion [ Time Frame: 12 Months, 24 Months ]1st MTP dorsiflexion and 1st MTP plantarflexion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740282
|Contact: Shana Zinkfirstname.lastname@example.org|
|Contact: Lisa A Kennedyemail@example.com|
|United States, Colorado|
|Foot & Ankle Center of Northern Colorado||Recruiting|
|Greeley, Colorado, United States, 80634|
|Contact: Daniel Hatch, DPM 970-351-0900 firstname.lastname@example.org|
|Contact: Kendi Strietzel 970-351-0900 email@example.com|
|United States, Iowa|
|Foot & Ankle Center of Iowa||Recruiting|
|Ankeny, Iowa, United States, 50023|
|Contact: Paul Dayton, DPM 515-639-3775 firstname.lastname@example.org|
|Contact: Cheyanne Lepird (712) 209-3600|
|Principal Investigator: Paul Dayton, DPM|
|Sub-Investigator: Mindi Dayton, DPM|
|United States, Missouri|
|Jefferson City Medical Group, P.C.||Recruiting|
|Jefferson City, Missouri, United States, 65109|
|Contact: Jody McAleer, DPM 573-556-7724 email@example.com|
|Contact: Jessica Vanderfeltz, LPN 573-556-7785 firstname.lastname@example.org|
|Principal Investigator: Jody McAleer, DPM|
|Sub-Investigator: William Duke, DPM|
|United States, Nevada|
|Desert Orthopaedic Center||Recruiting|
|Las Vegas, Nevada, United States, 89121|
|Contact: Abdolreza Raissi, MD 702-731-1616 email@example.com|
|Contact: Reyna Sanchez 702-731-1616 firstname.lastname@example.org|
|Principal Investigator: Abdolreza Raissi, MD|
|United States, Pennsylvania|
|University of Pennsylvania/Penn Medicine||Recruiting|
|Philadelphia, Pennsylvania, United States, 19106|
|Contact: Daniel C Farber, MD 215-829-3613 email@example.com|
|Contact: Warren Harding 215-829-3613 firstname.lastname@example.org|
|Principal Investigator: Daniel C Farber, MD|
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Contact: Dane Wukich 214-645-3336 email@example.com|
|Contact: Cynthia Wright 214-645-0423 firstname.lastname@example.org|
|Principal Investigator: Dane Wukich, MD|
|Sub-Investigator: George Liu, DPM|
|Sub-Investigator: Katherine Raspovic, DPM|
|Sub-Investigator: Trapper Lalli, MD|
|Sub-Investigator: Michael VanPelt, DPM|
|Stonebriar Foot & Ankle||Recruiting|
|Frisco, Texas, United States, 75034|
|Contact: Robert P Taylor, DPM 972-712-4161 email@example.com|
|Contact: Riley Davis 309-287-9497 firstname.lastname@example.org|
|Principal Investigator:||Dane Wukich, MD||UTSW|