SPECT-CT Metabolic and Morphological Study of Two Types of Cemented Hip Stem Protheses in Primary Total Hip Arthroplasty Patients: A Randomized Controlled Clinical Trial (SPECT-PROTMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Alignment angles in the plain radiography and in the CT scan study.
研究概览
简要总结
Single center, pilot, randomized, controlled clinical trial to assess metabolic and morphological images between two types of cemented stem prostheses in patients undergoing total hip arthroplasty surgery during a 2-year follow up period.
详细描述
Single center, pilot, controlled clinical trial to assess metabolic and morphological images of patients undergoing total hip arthroplasty surgery randomized to the thick layer technique (Exeter hip stem model) or to the "French paradox" technique (Müller straight stem model).
Participants will be performed a plain radiography and a SPECT-CT at 3, 6, 12 and 24 months of the intervention. SPECT-CTs will be performed in addition to the usual medical care complementary imaging exams. The SPECT will require the administration of the 99mTechnetium-methylene diphosphonate (99mTc-MDP) radiopharmaceutical (useful to assess bone metabolism) and its combination with a CT scan (SPECT-CT) allows a combined metabolic and morphological study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
After assignment to interventions (Exeter V40 cemented femoral stem or Müller THA), participant and surgeon team will be aware of the type of cemented stem prosthesis allocated. Since after randomization this is an open-label study, emergency unblinding does not apply. Data analysts will be blinded.
Personal patient data will be coded and dissociated, so that the patient to whom they correspond is not recognizable. Consecutive numbers will be assigned as they are enrolled in the study, and these numbers (or codes) will be used in the eCRF, rather than personal data.
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
- •patients ≥ 18 years-old
- •both genders
- •patients undergoing a primary total hip arthroplasty surgery with implantation of a cemented prosthesis (Exeter hip stem model or Müller straight stem model)
- •patients with a diagnosis of hip osteoarthritis, operated by the Orthopedic Surgery and Traumatology Department at the Bellvitge University Hospital
- •patients who signed the written informed consent.
排除标准
- •patients allergic to 99mTc-MDP radiopharmaceutical
- •patients with claustrophobia
- •patients with a background of an active septic process
- •patients with a postoperative septic complication
- •patients periprosthetic fracture or misalignment of the prosthetic component
- •patients who have a total hip prosthetic implanted due to a subcapital femoral fracture
结局指标
主要结局
Alignment angles in the plain radiography and in the CT scan study.
时间窗: 24 months after surgery
Number of counts per image set in the SPECT study
时间窗: 24 months after surgery
Counts per image: unit of measure defined as the number of photons captured by the gamma camera, which represent the radiopharmaceutical uptake
次要结局
- Harris Hip Score(24 months after surgery)
- EuroQoL-5D-3L questionnaire score(24 months after surgery)
- Harris Radiographic Classification of Loosening Risk.(24 months after surgery)
- WOMAC Index Score(24 months after surgery)
- Axial displacement in the plain radiography and in the CT Scan study.(24 months after surgery)
- Merle d'Aubigné Score(24 months after surgery)
研究者
Daniel Rodriguez Perez
Principal Investigator
Hospital Universitari de Bellvitge