Direct Skeletal Fixation of Prosthetic Limbs Following Trans- Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Condition of the skin surrounding the ITAP
研究概览
简要总结
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
详细描述
The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin. The device has been designed to be surgically implanted in a one stage procedure. In greater detail:
Intra-medullary stem - this component is designed to match the natural shape of the canal and is designed using the same principles established and used for the fixation of massive endo-prosthetic replacements. In certain cases a hydroxyapatite ceramic (CaPO4) coating is used, providing enhanced uncemented fixation. In other cases, depending on the geometry of the intramedullary canal, the stem can be fixed in place using acrylic bone cement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trans-femoral amputation
- •6 months or more attempted prosthetic rehabilitation (use of walking aids not relevant)
- •Between the ages of 18 to 60 inclusive
- •Length of stump: Sufficient bony stock for bony integration (at the investigator's discretion) and sufficient clearance (at the investigator's discretion) from medial joint line to accommodate failsafe device/ adaptor and knee mechanism
- •Suitable soft tissues to perform the operative procedure
- •Flexion Deformity (FFD) at hip no more than 15°
- •Normal range of flexion and adduction other than FFD
- •Oxford Grade 4 muscle power in all groups around hip
- •Normal contralateral leg function
- •Psychologically suitable (as deemed by screening process)
- •Sufficient standard of English to understand the Patient Information Sheet and general study requirements
- •Ability to understand and comply with study requirements - notably study timelines and additional clinic visits
- •Patients willing to take part in the study and sign the Informed Consent form
排除标准
- •Radiotherapy to target limb at any time
- •Chemotherapy within the preceding 12 months
- •Cognitive impairment likely to affect participation
- •Pre-existing ipsilateral hip pathology
- •Limited cardiorespiratory reserve / inability to walk at normal pace
- •Any significant co-morbidity that, in the investigator's opinion, is likely to affect outcome (e.g. osteoporosis, heart disease, peripheral vascular disease, obesity or unrelated cancer)
- •Any co-morbidity in the contra-lateral leg that precludes walking
- •Any significant previous infection within the previous 12 months, such as apical stump sepsis or dental sepsis
- •Using another silver-dosed medical device/treatment
- •Patients with hypersensitivity to silver
- •Concurrent medico-legal proceedings taking place
- •Patients currently included in other clinical trials
研究组 & 干预措施
Fixation of ITAP to lower limb amputees.
Direct skeletal fixation of ITAP to lower limb amputees. 20 patients in the study will be fitted with Intraosseous Transcutaneous Amputation Prosthesis.
The device has been designed to be surgically implanted in a one stage procedure.
干预措施: Direct skeletal fixation of ITAP to lower limb amputees. (Device)
结局指标
主要结局
Condition of the skin surrounding the ITAP
时间窗: 12 month post surgery
Skin reaction assessment reviews the presence of exudate
Pain at the end of stump
时间窗: 12 month post surgery
Skin reaction assessment reviews the pain in the skin area surrounding the ITAP
Adhesion check in the skin surrounding the ITAP
时间窗: 12 month post surgery
Skin reaction assessment reviews the adhesion to the Implant at surface layer
Assessment of skin colour surrounding the ITAP
时间窗: 12 month post surgery
Skin reaction assessment reviews the skin colour
Measuring temperature of the skin surrounding the ITAP
时间窗: 12 month post surgery
Skin reaction assessment reviews the temperature of the skin surrounding the ITAP and compares it to the other leg
Swelling of the skin around the ITAP
时间窗: 12 month post surgery
Skin reaction assessment reviews the swelling around the ITAP
次要结局
- Radiographic assessment to measure osseointegration(18 month post surgery)
- Gait analysis at 18 months to measure mobility(18 month post surgery)
- Subjective Qualitative Interview at 18 months to assess patient outcome(18 month post surgery)
- Radiographic assessments to measure fixation of the ITAP(18 month post surgery)
- Microbiological assessment of the stump by standard microbiological screen.(18 month post surgery)
- Calculate QTFA to measure quality of life(18 month post surgery)
- Calculate SIGAM to measure Limb specific mobility(18 month post surgery)
- Assessment of adverse events throughout the clinical trial(18 month post surgery)