NCT01237613终止不适用
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Orthopedic Foot and Ankle Center, Ohio2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
研究概览
简要总结
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
- •The patient has been informed about the study and signed the patient consent form.
- •The patient reads, understands and is able to complete the study questionnaires in English.
排除标准
- •The patient has an ongoing infection of the soft tissues of the ankle.
- •The patient has evidence of severe ankle arthritis.
- •The patient has a multi-system or multi-limb trauma.
- •The patient has a major medical condition that would affect quality of life and influence the results of the study.
- •The patient is pregnant
- •The patient is not expected to complete the study according to the investigation plan.
结局指标
主要结局
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
时间窗: 12 months
次要结局
- The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot(12 months)
- Subjective Evaluation of Treatment(12 months)
- Clinical Evaluation Including Adverse Events(12 months)
- General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire(12 months)
- Range of Motion, Strength and Calf Circumference(12 months)
- Return to Work and Previous Physical Activities(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
The Healing of Soft Tissue Augmentation by Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue GraftGingival Recession, GeneralizedGraft ReactionNCT03954028University of Florida
已完成
3 期
Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive CompoundACL InjuryNCT04993339University of Miami26
Enrolling By Invitation
不适用
Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament ReconstructionAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament InjuryNCT04650568Rush University Medical Center100
招募中
不适用
The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitisPeri-ImplantitisNCT05415111Nadja Naenni120
已完成
2 期
Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee InjuryOsteoarthritis, KneeNCT05016011Cytopeutics Sdn. Bhd.28