Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 8
- 主要终点
- Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
研究概览
简要总结
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.
详细描述
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate (Vanguard XP) by comparing it with a control group of patients implanted with an established single cruciate retaining device (Vanguard CR). The study also aims to examine short and long term descriptive cohort outcome data. A small preference cohort group of 60 patients receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data will be used to confirm the external validity of the RCT group and to contribute to the safety data for the British Orthopaedic Association's Beyond Compliance Programme.
Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Osteoarthritis of the knee involving one or more compartments of the joint.
- •Intact Anterior and Posterior Cruciate Ligaments.
- •Intact collateral ligaments.
- •Correctable coronal deformity.
- •No more than 15 degrees of fixed flexion deformity.
排除标准
- •Age under 18 years.
- •Revision knee replacement surgery.
- •Rheumatoid Arthritis.
- •Traumatic aetiology.
- •History or clinical signs of ACL rupture.
- •Previous arthroscopy related to ACL injury or reconstruction.
- •Correction of a flexion contracture that may require extensive resection of distal femur.
- •Altered pain perception and / or neurologic affection (for example as a complication arising from diabetes).
- •Unable to consent for themselves.
- •Patients with language or cognitive issues that may prevent them completing the follow up requirements.
- •Contraindications for the device:
- •Cementless application of components.
- •BMI ≥40 kg/m
- •Use of Anterior Stabilized Bearings.
- •Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees.
- •Correction or revision of previous joint replacement procedure on index knee.
- •Infection.
- •Sepsis.Osteomyelitis.
- •Osteoporosis (requiring treatment).
- •Relative contraindications include:
- •Unco-operative patient or patient with neurologic disorders who is incapable of following directions.
- •Osteoporosis.
- •Metabolic disorders which may impair bone formation.
- •Osteomalacia.
- •Distant foci of infections which may spread to the implant site.
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- •Vascular insufficiency, muscular atrophy, neuromuscular disease.
- •Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament.
研究组 & 干预措施
Vanguard XP Knee Replacement Surgery
Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee.
干预措施: Vanguard XP Bi-cruciate Retaining Knee Replacement System (Procedure)
Vanguard CR Knee Replacement Surgery
Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS.
干预措施: Vanguard CR Single Cruciate Retaining Knee System (Procedure)
结局指标
主要结局
Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)
时间窗: 3 years post randomisation
Patient Reported Outcome Score - disease specific
次要结局
- Forgotten Joint Score(Post operation (within 6 weeks), 1, 2 & 3 years post randomisation)
- Complications(Post operation (within 6 weeks), 1 & 3 years post randomisation)
- EQ-5D-3L(Post-operation (within 6 weeks); 1 & 3 years post randomisation)
- American Knee Society Score(Post operation (within 6 weeks), 1, 2 & 3 years post randomisation)