Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Periprosthetic Bone Mineral Density (BMD) of Hip
研究概览
简要总结
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation.
Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA.
Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up.
Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components.
The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
详细描述
none provided.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 85 years
- •Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
- •Stable Health: At the time of surgery based on physical examination and medical history.
- •Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
- •Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
排除标准
- •Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
- •Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
- •Patients with history of radiation therapy.
- •Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
- •Patients with known diagnosis of renal disease.
- •Patients with known diagnosis of osteoporosis.
- •Patients with history of steroid use in the hip joint region.
- •Patients that have had a previous lumbar fusion.
- •Patients whose surgical reconstruction required a pelvic cage or plate.
- •Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
- •Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (~2 years postoperative).
研究组 & 干预措施
Trabecular Metal Revision Cup
Patients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner.
干预措施: Trabecular Metal Revision Cup (Device)
Trabecular Metal Modular Cup
Patients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner.
干预措施: Trabecular Metal Modular Cup (Device)
结局指标
主要结局
Periprosthetic Bone Mineral Density (BMD) of Hip
时间窗: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
次要结局
- Functional and General Health Outcome Assessments(2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative)
研究者
Wael Barsoum
MD, Chairman of Surgical Operations
The Cleveland Clinic