Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- evaluation of screw resorption
研究概览
简要总结
From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.
The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).
The study will not present a control group or comparison groups between therapeutic procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 15 years at the time of surgery
- •Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
- •Minimum follow-up of 5 years
排除标准
- •Revisions/explantation of the endorthesis device
- •Patients with active acute or chronic infections
- •Patients with chronic inflammatory joint diseases
- •Patients with previous significant trauma of the lower limbs following surgery
- •Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
- •Patients with cognitive deficits
- •- Patients with concomitant neurological pathologies
- •Patients suffering from tumor pathology
- •Patients with cardiac pacemakers or other prostheses equipped with electronic circuits
- •Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures
- •Patients with orthopedic metal prostheses
- •Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material
- •Pregnant patients
- •Patients with insulin pumps and non-removable contact lenses
结局指标
主要结局
evaluation of screw resorption
时间窗: at baseline
Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery
Instrumental evaluation
时间窗: At baseline (Day 0)
Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant
次要结局
- clinical evaluation - Ankle-Hindfoot score(at baseline (day 0))
- Quality of life - SF-12(at baseline)