A Prospective, Non-comparative, Multi-centre, Post-market Clinical Study to Evaluate the Safety and Performance of the Carbon Fibre Reinforced Polyetheretherketone Metatarso-Phalangeal (MTP) Plate (CoLink® PCR MTP Plate) for the Treatment of Hallux Rigidus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Invibio Ltd
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Bone Fusion
研究概览
简要总结
The clinical study involves the routine treatment of skeletally mature patients who have been diagnosed with hallux rigidus (stiffness of the first metatarso-phalangeal joint in the foot due to arthritis and degeneration of cartilage).
It follows standard practice surgery to treat this condition. This type of degenerative arthritis affects the joint of the big toe (hallux) which is attached to the foot. Taking part in this research will involve collecting data of the surgery to remove damaged cartilage and fix the two bones together with screws and a plate (called the CoLink® PCR MTP Plate).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects aged 18 years of age or older (> 18 years) and are skeletally mature.
- •Subjects who require surgical treatment for hallux rigidus and have been evaluated as appropriate candidates for treatment with the CoLink® PCR MTP Plate by the Investigator.
- •Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.
排除标准
- •Subjects who have previously undergone MTP fusion surgery or implant arthroplasty in the foot to be treated.
- •Subjects who require bi-lateral MTP fusion surgery.
- •Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
- •Subjects with a known allergy to the material used in the instrumentation.
- •Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
- •Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
- •Female subjects who are pregnant or lactating.
- •Subjects who are known drug or alcohol abusers, or with a baseline opioid use greater than 30 mg of morphine equivalent/day, or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who are current smokers or have stopped smoking less than 6 months ago.
- •Subjects who are currently enrolled in a clinical study.
结局指标
主要结局
Bone Fusion
时间窗: 6 months
Successful radiographic union: where union is defined as 'evidence of bridging' between the metatarsal bone and proximal phalanx bone by an independent imaging company.
次要结局
未报告次要终点