Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Ankle radiographic angles
研究概览
简要总结
The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.
- •Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
- •Patients who have signed the "informed consent" approved by the Ethics Committee.
排除标准
- •Social conditions (homeless patients, with restrictions on personal freedom)
- •ASA 3 and 4
- •Deep venous insufficiency Lower limbs
- •History of Erisipelas lower limbs
- •Neurological or psychocognitive disorders
- •neurological diseases
- •Axial deformities of ankle >15°
- •Personal or family history of DVT or EP
- •Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
- •Pregnant women
- •Patients with rheumatic diseases
- •Patients that requires ancillary surgical procedures
研究组 & 干预措施
Traditional
In the STANDARD group, patients will undergo a primary TAR by implanting a prosthetic model of a standard design, that is the same for all using the usual surgical technique and instrumentation (based on the use of external leg guidance)
干预措施: Total ankle arthroplasty (Procedure)
Custom
In the PERSONALIZED group, patients will undergo a primary TAR by implanting a prosthetic model with a design specifically based on each patient's actual ankle morphology and using PSI surgical technique and instrumentation.
干预措施: Total ankle arthroplasty (Procedure)
结局指标
主要结局
Ankle radiographic angles
时间窗: 18 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
Ankle radiographic angles
时间窗: at baseline (day 0)
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
Ankle radiographic angles
时间窗: 3 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
Ankle radiographic angles
时间窗: 6 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
Ankle radiographic angles
时间窗: 12 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
次要结局
- Visual Analogic Scale(18 months)
- Ankle Range of motion(18 months)
- Short form 12(18 months)
- American Orthopedic Foot and Ankle Score(18 months)
- Short form 12(at baseline (day 0))
- Short form 12(3 months)
- Short form 12(6 months)
- Short form 12(12 months)
- Visual Analogic Scale(at baseline (day 0))
- Visual Analogic Scale(3 months)
- Visual Analogic Scale(6 months)
- Visual Analogic Scale(12 months)
- American Orthopedic Foot and Ankle Score(at baseline (day 0))
- American Orthopedic Foot and Ankle Score(3 months)
- American Orthopedic Foot and Ankle Score(6 months)
- American Orthopedic Foot and Ankle Score(12 months)
- Ankle Range of motion(at baseline (day 0))
- Ankle Range of motion(3 months)
- Ankle Range of motion(6 months)
- Ankle Range of motion(12 months)