All Ligaments Left In Knee Arthroplasty Trial: Multi-center clinical study comparing the clinical and patient reported outcomes of the vanguard XP knee system to the vanguard CR knee system

niversity of Oxford0 个研究点目标入组 77 人开始时间: 2017年7月14日最近更新: 2021年2月1日

适应症

试验速览

暂无简介。

•1. Primary Osteoarthritis of the knee involving one or more compartments of the joint
•2. Intact Anterior and Posterior Cruciate Ligaments
•3. Intact collateral ligaments
•4. Correctable coronal deformity
•5. No more than 15 degrees of fixed flexion deformity

•1. Age under 18 years.
•2. Revision knee replacement surgery
•3. Rheumatoid Arthritis
•4. Traumatic aetiology
•5. History or clinical signs of ACL rupture
•6. Previous arthroscopy related to ACL injury or reconstruction.
•7. Correction of a flexion contracture that may require extensive resection of distal femur
•8. Altered pain perception and / or neurologic affection due to diabetes.
•9. Contraindications for the knee implant:
•9.1. Cementless application of components*
•9.2. BMI =40 kg/m2 *
•9.3. Use of Anterior Stabilized Bearings*
•9.4. Patients with severe pre-operative varus or valgus deformity = 15 degrees*
•9.5. Correction or revision of previous joint replacement procedure on index knee*
•9.6. Infection
•9.7. Sepsis
•9.8. Osteomyelitis
•9.9. Osteoporosis (requiring treatment)
•10. Relative contraindications include:
•10.1. Unco-operative patient or patient with neurologic disorders who is incapable of following directions
•10.2. Osteoporosis
•10.3. Metabolic disorders which may impair bone formation,
•10.4. Osteomalacia
•10.5. Distant foci of infections which may spread to the implant site
•10.6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
•10.7. Vascular insufficiency, muscular atrophy, neuromuscular disease
•10.8. Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament*

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