Observational Plan Designed to Obtain Clinical Experience and Follow up Data on the Use of the ProxiFuse Hammer Toe Device for the Fixation of Osteotomies and Reconstruction of the Lesser Toes Following Correction Procedures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- PROMIS Pain Interference computerized adaptive test (CAT) score
研究概览
简要总结
This is a multi-center, non-randomized, observational study to further evaluate the effectiveness and safety of the Proxifuse Hammer Toe Device when utilized for bone fixation. Approximately 4 US sites will participate. The primary endpoint will evaluate the 6 month post surgery change from baseline in the PROMIS Pain Interference computerized adaptive test (CAT) score.
详细描述
This is an observational plan designed to obtain clinical experience and follow up data on the use of the ProxiFuse Hammer Toe Device for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Collection of data on patients treated with the FDA 510k approved ProxiFuse Hammer Toe Device will assist Cartiva in further evaluation of the effectiveness and safety of the ProxiFuse Hammer Toe Device when utilized for bone fixation per the specified indications. The ProxiFuse Hammer Toe Device is currently approved for commercial distribution and use in the country in which this protocol is being administered (FDA 510k approval K142490). . Given that the product is approved for distribution and use, the product is being used within its approved indication for use, and the data being collected is not burdensome or outside the standard of care, it is determined that no additional regulatory requirements are applicable to this data collection.
The ProxiFuse Hammer Toe Device consists of three components: the implant, deployment instrumentation, and bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves to shift the PEEK Body and to apply tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint.
In accordance with guidelines as outlined in ISO 14155, ICH GCP, and 21 CFR Part 50, each patient must grant documented informed consent and authorization of disclosure of identifiable health information prior to the collection of clinical data. Each patient should be informed of the procedures to be performed and that data will be collected. It is the intent to use de-identified research data for the potential purposes of product development and publication in marketing literature, journals, and peer-reviewed medical journals.
A copy of the signed informed consent document should be provided to the patient and the original should be maintained as part of the patient's clinical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Greater than 18 years of age
- •Has a hammertoe deformity causing daily pain and is a surgical candidate for hammertoe procedure in the 2nd, 3rd and/or 4th toe that has failed non-operative measures
- •Capable of completing self-administered questionnaires
- •Be willing and able to return for all study-related follow up procedures
- •Has not participated in any other research protocol within the last 30 days and will not participate in any other research protocol during this study
- •If female, is either using contraception or is postmenopausal, or male partner is using contraception
- •Has been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB
排除标准
- •Active bacterial infection of the foot/feet to be treated
- •Previous hammertoe correction that requires a revision to a toe to be treated under this study
- •Patient is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery
- •Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy
- •Patient is not ambulatory or requires an additional surgical procedure that would prohibit the patient from following standard ProxiFuse post-operative recovery procedures
- •Additional foot and ankle surgical procedures required during the index procedure other than foot procedures, lapidus and gastrocnemius recession
- •Suspected or known allergic reaction to Nickel or Titanium metals
- •Co-morbidity that reduces life expectancy to less than 12 months; or
- •Patient is a prisoner or ward of the state
结局指标
主要结局
PROMIS Pain Interference computerized adaptive test (CAT) score
时间窗: Change from baseline at 6 months
次要结局
- PROMIS Pain Interference CAT scores(Change from baseline at 2 weeks; 6 weeks and 3 months after surgery)
- PROMIS Physical Functioning CAT scores(Change from baseline at 2 weeks; 6 weeks; 3 months and 6 months after surgery)
- Time to return to normal shoe wear(Time recorded. Subjects will be queried at 2 weeks; 6 weeks; 3 months and 6 months and an actual date recorded. The number of days following surgery will be recorded for analysis)
- Postoperative Adverse Events that require a return to the operating room(From Operative time through 6 months)