NCT05082012终止不适用
Prospective Clinical StuDy of Tri-planar Tarsometatarsal (TMT) ArthroDesis With Early Weight-Bearing After Lapiplasty® ProceDure Through a Mini-Incision™ Approach (Mini3D)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 123
- 试验地点
- 19
- 主要终点
- Radiographic Recurrence
研究概览
简要总结
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
Up to 200 subjects will be treated in this study at up to 20 clinical sites. Patients 14 years through 58 years with symptomatic hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
详细描述
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery:
- To determine radiographic recurrence of hallux valgus and the timing of failure following hallux valgus correction with the Lapiplasty® Procedure.
- To determine whether the Lapiplasty® Procedure effectively corrects anatomical alignment of the 1st metatarsal and sesamoids in all three planes.
- To assess whether early weight-bearing after the Lapiplasty® Procedure affects the union rates or causes loss of 3-plane correction.
- To evaluate the quality of life and pain scores following the Lapiplasty® Procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 58 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
- •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.
排除标准
- •Patients satisfying the following criteria will not be eligible for participation:
- •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 concomitant procedures outside of the 1st ray;
- •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 HbA1c ≥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˚);
- •Known keloid and hypertrophic scar forming;
- •Scheduled to undergo a same-day 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 requires an incision >4.0 cm to complete the procedure (determined pre-operatively or intra-operatively);
- •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 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 the Treace ALIGN3D™ study without ongoing protocol defined AE; these are not exclusionary;
- •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.
结局指标
主要结局
Radiographic Recurrence
时间窗: 24 months
Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) \<9.0°, Hallux Valgus Angle (HVA)\<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4
次要结局
- Radiographic Healing(12 months post Lapiplasty® Procedure)
- Change in Pain(0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in Quality of Life(6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in Range of Motion(12 months, 24 months post Lapiplasty® Procedure)
- Change in Radiographic Foot Length(12 months post Lapiplasty® Procedure)
- Time to return to full unrestricted activity(6 weeks - 6 months, post Lapiplasty® Procedure)
- Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data(24 months post Lapiplasty® Procedure)
- Radiographic Angular/Positional Alignment(pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Time to start weight-bearing in a boot(0-3 weeks, post Lapiplasty® Procedure)
- Time to start weight-bearing in a shoe(6 weeks, post Lapiplasty® Procedure)
- Change in Radiographic Foot Width(12 months post Lapiplasty® Procedure)
- Change in Swelling at Foot, Ankle & Mid-Calf (Circumference)(6 weeks and 4 months post Lapiplasty® Procedure)
- Change in Scar Quality as Measured by Patient and Observer Scar Assessment Scale (POSAS)(4 months, 6 months, and 12 months post Lapiplasty® Procedure)
- Radiographic Angular Measurements(pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Number Of Patients With Radiographic Non-Union(12 months post Lapiplasty® Procedure)
- Clinical Complications Due to Lapiplasty® System Implants, the Procedure, the Post-op Weight-bearing Protocol or Health Conditions That Could Affect Other Outcome Measures - Measured by Adverse Events and Product Complaint Data(24 months post Lapiplasty® Procedure)
- Time to Start Weight-bearing in a Boot, in Days(0-3 weeks, post Lapiplasty® Procedure)
- Time to Start Weight-bearing in a Shoe(From time of procedure up to 6 weeks)
- Time to Return to Full Unrestricted Activity, in Days(From time of procedure up to 4 months)
- Change in Pain(6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in PROMIS - Quality of Life Score(6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in Quality of Life - MOxFQ(6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in Tibial Sesamoid Position (TSP)(pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
- Change in Osseous Foot Width (OFW)(pre-op, 6 weeks, 4 months, 6 months, 12 months, 24 months post Lapiplasty® Procedure)
研究者
研究点 (19)
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