NCT05587569招募中不适用
Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 17
- 主要终点
- Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
研究概览
简要总结
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.
Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years through 65 years with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
详细描述
The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery:
- To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.
- To determine whether the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females ≥14 years old at the time of consent
- •Closed physeal plates at the time of consent
- •Intermetatarsal angle is ≥8.0˚; OR True IMA of >10°, (IMA+MTA-15=True IMA)
- •Hallux valgus angle is ≥12.0˚
- •Metatarsus adductus angle based on Sgarlatos method ≥15°
- •Willing and able to adhere to post-op care instructions
- •Capable of completing self-administered questionnaires
- •Acceptable surgical candidate, including use of general anesthesia
- •Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the 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
- •Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure
排除标准
- •Previous surgery for hallux valgus on operative side
- •Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
- •Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
- •Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
- •Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
- •BMI >40 kg/m²
- •Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
- •Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
- •Current clinical diagnosis of peripheral neuropathy
- •Current clinical diagnosis of fibromyalgia
- •Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)
- •Current uncontrolled hypothyroidism
- •Current clinical diagnosis of chronic dependent edema
- •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 inhibit 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
- •Use of non-Treace products for Index Procedure
- •Additional bone procedure needed during the index procedure to complete correction [first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)];
- •Scheduled to undergo a same-day bilateral 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 weight-bear post-procedure
- •Patient is actively involved with a workman's compensation case or is currently involved in litigation
- •Patient is currently in, 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 either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE
- •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 of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
时间窗: 24 Months
Successful correction is defined as two of the following three criteria: measured IMA \<9.0°, HVA \<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \>15.0°.
次要结局
- Radiographic Recurrence(24 Months)
- Union vs non-Union(12 Months)
- Time to Weight-Bear in Shoes(8 Weeks)
- Change in Quality of Life(6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit)
- Change in Osseous Foot Width(12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit)
- Clinical Complications(60 Months)
- Weight-Bearing Recovery Time(12 Months)
- Time to Weight-Bear in Boot(6 Weeks)
- Change in Range of Motion(12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit)
- Time to Return to Unrestricted Activity(6 weeks - 6 months, post Lapiplasty® Procedure)
- Change in Pain(0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
不适用
Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck FractureFemoral Neck FracturesNCT02803983The Fuzhou No 2 Hospital30
招募中
不适用
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0Cervical DeformityNCT04194996International Spine Study Group Foundation200
终止
不适用
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"Pseudoarthrosis of the ClavicleNCT04041258Istituto Ortopedico Rizzoli20
已完成
不适用
Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder DislocationAnterior Shoulder DislocationBone DefectsShoulder InstabilityNCT04520087Istituto Ortopedico Rizzoli20
Unknown
不适用
Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADMBreast ReconstructionNCT03145337Musculoskeletal Transplant Foundation224