NCT00962143撤回不适用
Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to return to weight bearing
研究概览
简要总结
The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
- •Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
- •Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
- •Isolated Achilles tendon rupture without poly trauma
- •Patient must be 18 to 70 years of age
- •Life expectancy greater than or equal to 12 months
- •Patient is able to provide voluntary informed consent
- •Patient is willing and able to return for all follow-up visits and study related exams
- •Patient is willing to comply with prescribed physical therapy regimen
排除标准
- •Emergency, poly trauma patients
- •Previous Achilles tendon surgical procedure on that tendon
- •Deficit in the contralateral extremity that prevents a comparison with the treated extremity
- •Repair requires tendon lengthening, gap filling or tendon transfer
- •BMI greater than 40
- •Peripheral arterial disease
- •Uncontrolled Diabetes Mellitis
- •Patients whose injury is known to involve litigation
- •Known allergy to equine derived product
- •Systemic collagen disease
- •Neurological disease
- •Active infection - systemic or at the intended surgical site
- •Acute use of immunosuppressive agents
- •Rupture resulting from fluoroquinolone induced tendinopathy
- •Alcohol or drug abuse
- •Participant in another investigational drug or device trial
- •Pathologic soft tissue conditions that would prevent secure surgical fixation
- •Patients who are unwilling or unable to return for follow-up visits and study related exams
- •Pregnant women
- •Cancer patients
- •Decisionally impaired patients
- •Institutionalized patients
- •Prisoners
研究组 & 干预措施
Achilles repair without OrthADAPT Augmentation
Active Comparator
Achilles repair without OrthADAPT Augmentation
干预措施: Achilles repair without OrthADAPT Augmentation (Procedure)
Achilles repair with OrthADAPT augmentation
Experimental
Achilles repair with OrthADAPT augmentation
干预措施: Achilles repair with OrthADAPT augmentation (Device)
结局指标
主要结局
Time to return to weight bearing
时间窗: 2, 3, 4.5, 6, and 12 months
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
时间窗: 2, 3, 4.5, 6, and 12 months
Time to return to full activity
时间窗: 2, 3, 4.5, 6, and 12 months
次要结局
- Complication rate including re-rupture and incision wound healing delay(6 weeks, 2, 3, 4.5, 6 and 12 months)
- Incidence of device and procedure-related adverse events(6 weeks, 2, 3, 4.5, 6 and 12 months)
- Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores(6 weeks, 2, 3, 4.5, 6 and 12 months)
研究者
研究点 (1)
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