Five-year results of cervical disc prostheses in the SWISSspine registry

被引:24
作者
Aghayev, Emin [1 ]
Baerlocher, Christian [2 ]
Sgier, Friedrich [3 ]
Hasdemir, Mustafa [4 ]
Steinsiepe, Klaus F. [5 ]
Wernli, Frank [4 ]
Porchet, Francois [6 ]
Hausmann, Oliver [3 ]
Ramadan, Aymen [7 ]
Maestretti, Gianluca [8 ]
Ebeling, Uwe [5 ]
Neukamp, Michal [1 ]
Roeder, Christoph [1 ]
机构
[1] Univ Bern, Inst Evaluat Res Orthoped Surg, CH-3014 Bern, Switzerland
[2] Stephanshorn Hosp, CH-9016 St Gallen, Switzerland
[3] St Anna Clin, CH-6006 Luzern, Switzerland
[4] Salem Hosp, CH-3000 Bern, Switzerland
[5] Lindenhof Hosp, CH-3001 Bern, Switzerland
[6] Schulthess Klin, CH-8008 Zurich, Switzerland
[7] Clin La Colline, CH-1206 Geneva, Switzerland
[8] Hop Cantonal Fribourg, CH-1708 Fribourg, Switzerland
关键词
SWISSspine; TDA; Disc arthroplasty; Cervical disc prosthesis; Long-term follow-up; INVESTIGATIONAL DEVICE EXEMPTION; RANDOMIZED CONTROLLED-TRIALS; RADIOGRAPHIC FOLLOW-UP; HETEROTOPIC OSSIFICATION; CLINICAL ARTICLE; SINGLE-LEVEL; REPLACEMENT; ARTHROPLASTY; DISEASE; FUSION;
D O I
10.1007/s00586-013-2770-0
中图分类号
R74 [神经病学与精神病学];
学科分类号
100204 [神经病学];
摘要
The Swiss Federal Office of Public Health demanded a nationwide HTA-registry for cervical total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of cervical TDA. Three hundred thirty-two cases treated between 3.2005 and 6.2006 who were eligible for 5 years follow-ups were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 84.6, 74.4, 50.6 and 64.8 %, respectively. Outcome measures were neck and arm pain, medication, quality of life, intraoperative and postoperative complication and revision rates. In addition, segmental mobility, ossification, adjacent and distant segment degeneration were analyzed at the 5-year follow-up. There was significant, clinically relevant and lasting reduction of neck (preop/postop 60/21 VAS points) and arm pain (preop/postop VAS 67/17) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.39/0.82 EQ-5D points) until the 5-year follow-up. The rates for intraoperative and early postoperative complications were 0.6 and 7.2 %, respectively. In 0.6 % an early and in 3.9 % a late revision surgery was performed. At the 5-year follow-up, the average range of motion of the mobile segments (88.2 %) was 10.2A degrees. In 40.7 % of the patients osteophytes at least potentially affecting range of motion were seen. Cervical TDA appeared as safe and efficient in long-term pain alleviation, consequent reduction of pain killer consumption and in improvement of quality of life. The improvement is stable over the 5 years postoperative period. The vast majority of treated segments remained mobile after 5 years, although 40.7 % of patients showed osteophytes.
引用
收藏
页码:1723 / 1730
页数:8
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