ISRCTN57876689进行中（未招募）Unknown
Performance and function of the Trident® II 3D printed acetabular component
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant female between 40 and 75 years of age with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (PTA) and requiring primary THA and is suitable for the use for the uncemented Trident II acetabular component, in combination with any Stryker liner and any compatible femoral head and stem.
- •2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
- •3. Patient is able to understand and provide written consent.
- •4. Patients with no clinically relevant disorders undergoing THA.
排除标准
- •1. Patients deemed by the treating surgeon to be unable to comply with the prescribed post-operative routine and follow-up evaluation schedule.
- •2. Patients with rheumatoid arthritic hip as well as history of acetabular or femoral osteotomy.
- •3. Patients who have had a THA on the contra-lateral side within last 6 months.
- •4. Patients who are likely to need further lower limb joint replacement for another joint within one year.
- •5. Female patients between the ages of 40 and 75 years that are pregnant or planning a pregnancy up to 1 year during which they would have received the implant.
- •6. Patients who require revision of previously implanted THA.
- •7. Patients with active or suspected infection, requiring treatment.
- •8. Patients with active malignancy.
- •9. Patients diagnosed with systemic disease that would affect patient’s welfare or overall outcome of the study (severe osteoporosis, Paget’s Disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
- •10. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient’s ability to limit weight bearing or places an extreme load on the implant during the healing period.
- •11. Patients with systemic or metabolic disorders leading to progressive bone deterioration (such as rickets, osteomalacia, osteogenesis, imperfecta, marble bone disease, (osteopetrosis), Paget disease of bone and fibrous dysplasia).
- •12. Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis or renal disease requiring dialysis.
- •13. Patients with a body mass index (BMI), kg/m² > 40. Obese patients where obesity is severe enough to affect patient’s ability to perform activities of daily living.
- •14. Is the patient involved in a research study that, in the opinion of the PI, would affect their continued participation in the previous study and/or would affect the current study intervention and/or their treatment outcomes.
研究者
相似试验
招募中
不适用
Investigation of 3D-printed bone implants in surgeries of eye orbit lesionsIRCT20220807055633N3Esfahan University of Medical Sciences500
招募中
不适用
Evaluation of the potential of Real-Time 3-Dimensional echocardiography in the assessment of right ventricular function in patients with congenital heart disease: comparison of RT-3D echo with MRI.Congenital heart diseasecongenital heart defects10007510NL-OMON33891Erasmus MC, Universitair Medisch Centrum Rotterdam175
进行中（未招募）
不适用
Phase II parallel studies on the use of 3D-radiotherapy plus Amifostine or IMRT to evaluate xerostomia reduction in patients with head and neck cancer treated in definitve or postoperative setting.subcutaneous amiphostine with 3D-radiotherapy to reduce xerostomiaEUCTR2004-004288-31-ITISTITUTI FISIOTERAPICI OSPITALIERI
已完成
不适用
Evaluation and Validation of the Digital-Triplet-Test for normal Hearing poeple and CI recipientsZ96.8Presence of other specified functional implantsDRKS00018819Vivantes Klinikum Friedrichshain - Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie40
招募中
不适用
Three-dimensional documentation and evaluation of the nasolabial region of children with cleft lip and palateCleft palateCleft lipQ36Q37Q35Cleft palate with cleft lipDRKS00032280Mund-, Kiefer- und Gesichtschirurgische Klinik des Universitätsklinikums Erlangen100