Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With Intraoperative Complications
研究概览
简要总结
The objective of this study is to prospectively evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent double or triple arthrodesis using CCS screws.
详细描述
This proposal is a collaborative effort of Medartis. This is a prospective investigation to evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent subtalar,double or triple arthrodesis using CCS screws.The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Patients undergoing a double or triple arthrodesis in their foot using Aptus CCS screws will be asked to enroll in this study. After informed consent, the patients will be asked to complete the following patient reported outcomes questionnaires (standard of care for all patients in the Foot and Ankle section): VAS for pain, modified Coughlin rating scale, AOFAS, and FADI at each standard of care visit which includes preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years post operative. Patients will also receive standard of care radiographs at these visits, and a standard of care CT scan at 6 months.
Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone over age 18 who has Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints, and/or Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction, and/or Neuromuscular disease mediated hindfoot deformities, and/or Tarsal coalitions, and/or Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot.and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the only exclusion criteria will be patients who are not healthy enough to undergo surgery. Approximately 50 patients will be recruited for the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints (2;12).
- •Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction (e.g. grade IV) (4;13-15).
- •Neuromuscular disease mediated hindfoot deformities (16).
- •Tarsal coalitions (17).
- •Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot.
- •Between the age 18-75
排除标准
- •Acute or chronic infection.
- •Poor vascular status of the lower leg (relative contraindication for double arthrodesis through a single medial approach).
- •Women that are pregnant.
结局指标
主要结局
Number of Participants With Intraoperative Complications
时间窗: At time of surgery
All intraoperative complications including injury of neurovascular structures and/or tendons will be prospectively documented. All intraoperative technical difficulties (for example, breakage of the screw) will be prospectively documented.
Number of Participants With Perioperative Complications
时间窗: Up to 2 years post-operative
All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented.
Number of Participants With Delayed Osseous Union or Non-union
时间窗: Up to 2 years post-operative
Independent radiologist will measure fusion of standard of care radiographs and CT scan
Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal
时间窗: Up to 2 years post-operative
All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented.
Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment
时间窗: Up to 2 years post-operative
An independent radiologist will measure fusion of the double, triple, or subtalar fusion by reviewing the standard of care radiographs and CT scan and measuring the rate of fusion using the bridging of the trabecular bone.
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS)
时间窗: Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative
The VAS ranges from 0 (no pain) to 10 (maximal pain).
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score
时间窗: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
The final score is the sum of the points across all 9 questions with a total score range of 0 to 28. A higher score indicates greater functionality.
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score
时间窗: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality.
次要结局
未报告次要终点