NCT05460715进行中（未招募）不适用
Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluate the 10-year survival of the anteverted Quadra-P stem
研究概览
简要总结
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
详细描述
The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.
Secondary objectives:
- To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
- Assessment of functional recovery by gait analysis study
- Collect the rate of complications throughout the course of the study
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis
- •Adult subjects between 18 and 75 years of age on the date of surgery
- •Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant
- •Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery.
- •For the anatomical-functional subgroup:
- •- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.
排除标准
- •Subjects with acute or chronic infection
- •Subjects with a femoral neck fracture
- •Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits
- •Subjects with severe deformities, at the discretion of the surgeon
- •Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated
- •Subjects with muscular atrophy or neuromuscular diseases
- •Subjects allergic to the materials used during surgery
- •Subjects unable or unwilling to provide consent for participation in the study
- •Any other condition not mentioned in the inclusion criteria
结局指标
主要结局
Evaluate the 10-year survival of the anteverted Quadra-P stem
时间窗: 10 years
% survival rate
次要结局
- Assessing the patient's perception of the prosthetic joint(at 3 months and at 1, 2, 5, 7 and 10 years after surgery.)
- Collect the rate of complications(at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years.)
- Assess clinical performance(at 3 months, 1, 2, 5, 7 and 10 years.)
- Assessment of functional recovery(at pre-op, 3 months and at 1 year after surgery.)
- Assess radiological performance(at pre-op, 3 months, 1, 2, 5, 7 and 10 years.)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
The Medacta International AMIStem-P Post-Marketing Surveillance StudyArthrosisTraumatic ArthritisRheumatoid PolyarthritisCongenital Hip DysplasiaAvascular Necrosis of the Femoral HeadNCT04997005Medacta International SA550
Unknown
不适用
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)Back PainScoliosisNCT02659722Vertebral Technologies, Inc.200
已完成
不适用
Prospective Observational Study for the Evaluation of VEOFIX Varisation StaplesHallux ValgusNCT05523219Societe dEtude, de Recherche et de Fabrication81
已完成
不适用
Multi Centre Study on TESS V2 Shoulder SystemOsteoarthritis ShoulderRevisionRheumatoid ArthritisAvascular NecrosisFractureRotator Cuff TearNCT03431857Zimmer Biomet106
已完成
4 期
Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract SurgeryCataractNCT02023437Technolas Perfect Vision GmbH132