Hallux Valgus Clinical Trial
— ALIGN3DOfficial title:
Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesIs With Early WeiGht-BeariNg After Lapiplasty ProcDure (ALIGN3D)
Verified date | September 2023 |
Source | Treace Medical Concepts, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 183 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 58 Years |
Eligibility | Inclusion Criteria: - Male and females between the ages 14 and 58 years at the time of consent - Closed physeal plates at the time of consent - Intermetatarsal angle is between 10.0 ° - 22.0 ° - Hallux valgus angle is between 16.0 ° - 40.0 ° - Willing and able to adhere to early weight-bearing instructions post-operatively - Capable of completing self - administered questionnaires - Acceptable surgical candidate, including use of general anesthesia - Female patients must be of non-child bearing potential or have a negative pregnancy test within 7 days prior to 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 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 or lesser toes/digits) - Additional arthrodesis outside the first tarsometatarsal joint (other than: arthrodesis between the medial cuneiform and intermediate cuneiform and/or base of 2nd metatarsal; arthrodesis of hammertoe proximal interphalangeal joint or lesser toes/digits) - Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging (including lack of evident crista) or positive grind test - Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5 °and talonavicular subluxation/uncovering >50%) - BMI >40 kg/m² - Current nicotine user, including current use of nicotine patch - Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or HbA 1c =7.0 - Current clinical diagnosis of peripheral neuropathy or by assessment on 4 - point monofilament test - Current clinical diagnosis of fibromyalgia - Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD) - Current uncontrolled hypothyroidism - 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 retard 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 - Current diagnosis of metatarsus adductus (defined as MAA = 23 °) - Scheduled to undergo a same - bilateral procedure. Patient agrees to refrain from the Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for minimum of 6 months post index 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 early weight-bear post-procedure - Patient is actively involved with a workman's compensation case or is currently involved in litigation - Patient is currently or has participated in a clinical study in the last 30 days prior to signing - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Foot & Ankle Center of Iowa | Ankeny | Iowa |
United States | UT Southwestern | Dallas | Texas |
United States | Stonebriar Foot & Ankle | Frisco | Texas |
United States | Foot & Ankle Center of Northern Colorado | Greeley | Colorado |
United States | Jefferson City Medical Group, P.C. | Jefferson City | Missouri |
United States | Desert Orthopaedic Center | Las Vegas | Nevada |
United States | University of Pennsylvania/Penn Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Treace Medical Concepts, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiographic recurrence of hallux valgus | Defined as IMA = 12, HVA = 20 and TSP as = 4 at 24 Months post Lapiplasty Procedure | 24 Months | |
Secondary | Change in radiographic angular/positional alignment before and after the Lapiplasty Procedure | Intermetatarsal Angle (IMA), Hallux Valgus Angle (HVA) and Tibial Sesamoid Position (TSP) | Pre-operatively, 6 Weeks, 4 Months, 6 Months, 12 Months, 24 Months, 36 Month, 48 Months, 60 Months | |
Secondary | Clinical/radiographic healing | 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 | 12 Months | |
Secondary | Clinical complications | Complications due to the Lapiplasty procedure device or post-operative protocol or health conditions that could affect other health outcomes | 24 Months | |
Secondary | Time to start of weight-bearing in boot | The time needed for a study subject to begin bearing weight in a boot after the Lapiplasty Procedure | 0-3 Weeks | |
Secondary | Time to start of weight-bearing in shoes | The time needed for a study subject to begin bearing weight in a shoe after the Lapiplasty Procedure | 0-12 Weeks | |
Secondary | Time to return to full unrestricted activity | The time needed for a study subject to return to full unrestricted activity after the Lapiplasty Procedure | 6 Weeks to 12 Months | |
Secondary | Change in Visual Analog Scale (VAS) Pain Score | Patient reported foot pain intensity/0 (no pain) - 10 (worst possible pain) | Pre-operatively, 6 Weeks, 4 Months, 6 Months, 12 Months, 24 Months, 36 Month, 48 Months, 60 Months | |
Secondary | Change in PROMIS-29 score across multiple time-points | 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. | Pre-operatively, 6 Months, 12 Months, 24 Months | |
Secondary | Change in PROMIS-25 score across multiple time-points | 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. | Pre-operatively, 6 Months, 12 Months, 24 Months | |
Secondary | Change in MOxFQ Foot Problems score across multiple time-points | 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 | Pre-operatively, 6 Months, 12 Months, 24 Months | |
Secondary | Change in Range of Motion | 1st MTP dorsiflexion and 1st MTP plantarflexion | 12 Months, 24 Months |
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