A Randomized Controlled Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine. A Comparison on Clinical Outcome and Facet-joint Load Between Two Different TDR Designs.
试验速览
- 阶段
- 不适用
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Patient reported back pain after two years in Swespine national registry
研究概览
简要总结
TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility. Lately interest is growing on non-mechanical implants that could possibly provide/restore mobility, but also produce counterforces on mobility as in healthy discs. No previous comparison between these two concepts has been performed, neither on clinical outcome, neither on specific differences on facet-joint load and wear.
详细描述
A total of 250 patients are to be enrolled and treated. Inclusion criteria is unbearable pain and dysfunction from degenerative disc disease (DDD) that at one or two segments in the lover lumbar spine, that has not responded positively from at least one year of conservative treatment (that is combination of intense physical training and drugs).
Patients with DDD below L3 vertebra are divided I three groups:
- One segment DDD appropriate for treatment with TDR.
- Two segments DDD appropriate for treatment with TDR.
- One segment DDD appropriate for treatment with TDR and one segment DDD not appropriate for treatment with TDR, that will be treated with anterior fusion (ALIF) at the same surgical procedure, called "hybrids". Within all three groups there will be an equal randomization between the two prosthesis types.
Clinical outcome will be evaluated from questionnaires sent out to patients after 12- and 24 months and 5- and 10 years after surgery. The questionnaire are the currently used ones from the Swedish Spine Registry (SweSpine) including VAS leg/back, EuroQol ,GA and ODI. Complications will be registered continuously and facet-joint load/health will be examined from flex-ext x-rays at 1 and 2 years. At the 2-year check up a 3D-CT will be performed to further evaluate the facet joints and their load under flex-ext.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incapacitating pain from DDD (both clinical and radiological) in one or two segments below the L3 vertebra, were at least one segment is suitable for TDR treatment.
- •Patient with more than one year of pain, that has during this period made a prolonged and adequate conservative program.
- •Patient between 20 and 55 years of age. -
- •Patient able to understand written and spoken Swedish.
排除标准
- •Patient does not accept to be part of the study.
- •Three or more segments suspected to be symptomatic.
- •Earlier vertebral fracture, tumour, infection or fusion in the lumbar spine. -Substantial scoliosis/deformity.
- •Need for posterior decompression.
- •Pregnancy, psychiatric illness or drug abuse. -Patient does not understand written and spoken Swedish and can thus not take part in information and answer questionnaires.
- •Patient residing outside Sweden and thus is not covered with SweSpine. -
研究组 & 干预措施
ORBIT Mechanical disc prosthesis
Surgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical"
干预措施: Device: ZACK (Procedure)
ZACK viscoelastic disc prosthesis
Surgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics"
干预措施: Device: ORBIT (Procedure)
ORBIT SASCA
Surgical procedure with total disc replacement (TDR) using ORBIT disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.
干预措施: Device: ZACK (Procedure)
ORBIT SASCA
Surgical procedure with total disc replacement (TDR) using ORBIT disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.
干预措施: Device: SASCA (Procedure)
ZACK SASCA
Surgical procedure with total disc replacement (TDR) using ZACK disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.
干预措施: Device: ORBIT (Procedure)
ZACK SASCA
Surgical procedure with total disc replacement (TDR) using ZACK disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.
干预措施: Device: SASCA (Procedure)
结局指标
主要结局
Patient reported back pain after two years in Swespine national registry
时间窗: 2, 5, 10 years
GA (Global Assessment of back pain, patient-based evaluation of leg and back pain as compared to preoperatively,1-5, 1 disappeared and 5 worsened) ,collected from questionnaires
次要结局
- VAS, Visual Analogue Scale(2, 5, 10 years)
- Re-operation related to facet-joint arthritis(2, 5, 10 years)
- Facet-joint pathology prevalence(2, 5, 10 years)
- EQ-5D, Health-related quality of life(2, 5, 10 years)
- Postoperative complications(Two years after the last patient is treated)
- ODI, Oswestry disability index(2, 5, 10 years)
研究者
Svante Berg
MD, PhD, Associate Professor, Senior Consultant
Karolinska Institutet