The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Inion Oy
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events (AEs)
研究概览
简要总结
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
详细描述
The study in question is a post market clinical follow-up study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.
The Inion CompressOn™ screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The screws retain their initial strength up to 12 weeks after implantation and gradually lose their strength thereafter. Bioabsorption takes place within two to four years. The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In the field of foot and ankle traumatology the surgical indications of this study include medial malleolar fractures, Lisfranc injuries, talus fractures, calcaneal fractures and navicular bone fractures. In the field of foot and ankle orthopaedics the surgical indications of the study include arthrodesis of the talonavicular joint, calcaneacuboideal joint, tarsometatarsal joint and first metatarsophalangeal (MTP1) joint, and osteotomies of the first metatarsal bone, second metatarsal bone (weil) and calcaneal bone.
The clinical data collection acquired from this study is a requirement of the EU Notified Body as part of the admitted CE mark certification, in cases when the device is initially approved based on the clinical data of an equivalent device. In this case, the equivalent device has been Inion FreedomScrew, which is made of the same material composition and has the same indications for use. Inion CompressOn Screw has new design features such as headless design, and threading which allows compression to the fracture line. Also new sizes are introduced.
The study recruits 125 adult patients who meet the acceptance criteria and have signed the informed consent. The follow-up time for each study patient is 4 years. Each patient has 6 follow-up time points related to the study. These time points consist of:
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
- •Read the patient information bulletin on the study and signed the patient consent form
- •Adult patient (over 18-year-old)
- •Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
- •Ability to fill in questionnaires.
- •Willingness to comply with rehabilitation instructions.
- •Availability for follow-up visits.
排除标准
- •Active infection
- •Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb
- •Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
- •Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
- •High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
- •Patients with significant neuropathy
- •Patients who refuse to participate
- •Lower limb tumor or metastasis
- •Complex Regional Pain Syndrome (CRPS) in operated foot
研究组 & 干预措施
CompressOn group
125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws.
干预措施: Operation (Procedure)
结局指标
主要结局
Occurrence of adverse events (AEs)
时间窗: During 4-year follow-up
Assessment of occurrence of adverse events (AE), such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
时间窗: Change from operation to 4 years
X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines
Occurrence of revision surgeries
时间窗: During 4-year follow-up
Assessment of occurrence of revision surgeries related to study device
次要结局
- Fixation strength(Change from operation to 4 years)
- Subjective functionality of the operated foot or ankle (VAS foot and ankle)(Change from baseline to 4 years)
- Subjective functionality of the operated foot or ankle (EFAS)(Change from baseline to 4 years)
- Wound and soft tissue healing(Change from operation to 3 months)
- Bone formation in screw tunnel(Change from operation to 4 years)