Five-year Migration Pattern and Changes in Bone Mineral Density for the Tri-Lock and Summit Femoral Stems - Radiostereometric Analysis and Dual-energy X-ray Absorptiometry of 50 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Migration (3D rotation and translation) Measured with radiostereometric analysis (RSA)
研究概览
简要总结
The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over 15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and 78 % over 15 years.
As revision surgery is associated with higher complication risk for the patient and poorer out-come and implant survival it is necessary to examine possible methods that may increase long-term survival of the primary hip prosthesis or facilitate better outcomes after revision of hip joint prostheses for younger patients.
In younger patients the prosthesis often is inserted without the use of cement. When not using cement, it is crucial for the final result, that there is a direct bone ingrowth of the prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic surface.
This study investigates a new bone sparing implant with a new surface compared to a conventional implant.
详细描述
BACKGROUND
According to the Danish Hip Arthroplasty Registry 201 approximately 10.400 primary hip joint prostheses in Denmark are implanted annually, and the incidence is relatively stable. The incidence of primary hip joint prosthesis in population was 180 per. 100,000 inhabitants in 2014, with a slight predominance of female patients (60%). The average age for women is 70 and for men 67 years. Idiopathic arthritis is diagnosed in 80% of all patients receiving a hip joint prosthesis [1,2]. For older patients, the risk of later revision of a hip joint prosthesis is small. The overall survival of the primary hip joint prostheses is for all diagnoses 82% after 19 years. The prosthesis survival is poorer for younger patients, and for women. In male patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over 15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and 78 % over 15 years. [2]. As revision surgery is associated with higher complication risk for the patient and poorer outcome and implant survival it is necessary to examine possible methods that may increase long-term survival of the primary hip prosthesis or facilitate better outcomes after revision of hip joint prostheses for younger patients.
In younger patients the prosthesis often is inserted without the use of cement. When not using cement, it is crucial for the final result, that there is a direct bone ingrowth of the prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic surface. From a theoretical point of view it is also important that elastic properties of the prosthesis differ as little as possible from the elastic properties of the bone, in order to prevent a subsequent loss of bone.
INVESTIGATED IMPLANTS
The Tri-Lock femoral implant from Depuy ® is in its basic design a well-known implant that has been used since 1981 with documented good long-term results. It is an implant with bone-preserving properties and proximal coating, providing a predominantly metaphyseal anchoring. The Summit femoral implant from Depuy ®, is newer to the marked, and has a longer diaphyseal support but is predominantly metaphyseally fixed. A proximal porous implant coating will increase the surface area in contact with the metaphyseale bone and increase the coefficient of friction compared to mid-coated implants [3,4,5]. Proximal coatings may on the positive side lessen periprosthetic bone stress shielding, however, on the negative side, proximal coatings may reduce primary prosthesis fixation and lead to fibrous membrane formation with consequently implant micromotions that will eventually causing aseptic loosening of the im-plant. Hypothetical extensively coated implants have a larger porous surface and thus provide better and faster primary fixation, but there are no publications of randomized prospective clinical studies to support this. There are different porous coatings on the two investigated femoral components. Summit is coated with Porocoat porous coating, whereas Tri-Lock in the latest version is coated with the new GRIPTION technique for an even larger surface for bone ingrowth (Gription) with a new ultra-porous surface marketed as an improved immediate im-plant fixation in the bone. The total surface of the metaphyseal implant part is increased by approximately 25% with the Gription coating technique. The Gription technique may provide consistent implant seating height and additional initial stability, and these qualities may in long term ensure an improvement on implant survival.
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
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary hip osteoarthritis
- •Patients with adequate bone stock for insertion of uncemented components(no osteoporosis as assessed by pre-operative dual-energy x-ray absorptiometry (DXA) scans)
- •Informed, written consent
排除标准
- •Patients with neuromuscular or vascular diseases in the affected leg
- •Patients intraoperatively found unfit to uncemented components
- •Patients who can not refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) in post-operative recovery
- •Patients with pre-operative fracture sequelae
- •Women who are, or have a wish for pregnancy during the study period.
- •Hip dysplasia or sequelae to Calves Perthes.
结局指标
主要结局
Migration (3D rotation and translation) Measured with radiostereometric analysis (RSA)
时间窗: 5 years
Subsidence (distal translation mm) and retroversion (negative vertical rotation deg.)
Bone mineral density (BMD) measured with dual-energy x-ray absorptiometry
时间窗: 5 years
By Gruen zones, calculated as changes from baseline recording.
次要结局
- Patient perceived hip function measured with Oxford hip score (OHS)(5 years)
- Pain measured on a visual analog scale (VAS)(5 years)
- Health related quality of life measured with EuroQol-5 Domain (EQ5D)(5 years)
研究者
Torben B. Hansen
Professor, MD PhD
Regional Hospital Holstebro
