Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies: A Non- Inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Bone healing
研究概览
简要总结
The use of bio-integrative implants in orthopedic surgery is growing exponentially. As many biomechanical and histological studies were able to sustain its structural and biological properties, few clinical studies are available to support its advantages, such as good osteosynthesis, lower rates of removal, and diminished implant-related artifact in imaging studies. This information is vital to providers when choosing the proper material and planning postoperative treatment. This trial intends to test the capacity of the bioabsorbable screws in reaching the same clinical and radiographical outcomes of the current metallic screws.
详细描述
A minimum of 44 patients undergoing Medial or Lateral Displacement Calcaneal Osteotomy (MDCO) will be randomized in two parallel groups for surgery, considering applied the implant. One group will be operated using two 4.0mm cannulated bio-integrative (absorbable) screws, and the other group using two 4.0mm cannulated metallic screws. Patients will be blinded evaluated for a mean follow-up of twelve weeks in terms of bone healing, complications, and implant-related artifact using weight-bearing computed tomography (WBCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The evaluator doctor will not have access to the protocol test applied to each patient and the surgeries will be conducted by different physicians.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must be older than 18 and younger than 75 years of age, both genders;
- •Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery;
- •Clinical diagnosis of hindfoot malignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus;
- •Surgical planning, including a calcaneus displacement osteotomy through a traditional oblique cut.
排除标准
- •Previous surgery involving the affected calcaneus;
- •History or documented evidence of autoimmune or peripheral vascular diseases;
- •History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
- •Any condition that represents a contraindication of the proposed therapies;
- •Impossibility or incapacity to sign the informed Consent Form;
- •Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
- •Osteotomies requiring resection of wedges (Dweyer, triple Dweyer, etc.);
- •Osteotomies planned to occur in a non-traditional cut (Malerba, Scarf, etc.).
结局指标
主要结局
Bone healing
时间窗: 6 weeks
\- Amount of bone bridging crossing the osteotomy site: Determined by the percentage of bone trabeculae crossing the osteotomy site on every tomography cut (amount of the cut in millimeters that shows bone spanning the two fragments divided by the total amount of osteotomy's surface on the cut). \- Weight-bearing computed tomography (WBCT) acquisitions will be used to determine this percentage.
次要结局
- Complications(6 weeks)
- Implant-related artifact(6 weeks)
研究者
John Femino
Assistant Professor
University of Iowa