Functional Advantages of TRIGEN™ INTERTAN™ Over Sliding Hip Screw in Subjects With Trochanteric Hip Fracture: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Functional Independence Measure (motor portion)
研究概览
简要总结
The purpose of this study is to compare the Trigen InterTAN Intramedullary nail to Sliding Hip Screws in AO/OTA 31-A1 and A2 intertrochanteric hip fractures.
详细描述
A multicentre, randomised controlled trial, conducted in the UK will recruit 180 subjects, randomised to receive either the Trigen InterTAN Nail or the Sliding Hip Screw.
Subjects presenting at participating hospitals with AO/OTA 31-A1 or A2 fractures will be assessed against the eligibility criteria and approached for Informed Consent.
Subjects who are considered eligible and who have provided Informed Consent will be randomised using iDataFax to one of the two treatment options.
Subjects will be operated on according to standard procedure and the Instructions for Use.
A daily inpatient assessment will record the subjects use of opioid pain medication.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has closed trochanteric hip fracture (AO/OTA 31-A1 or A2) requiring treatment with internal fixation
- •has injury due to low energy trauma
- •is independently ambulatory in living environment prior to injury (walking aids permitted)
- •is >60 years of age
- •is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
- •has consented to participate in the study by signing the Ethics Committee (EC) approved ICF
- •has definitive fracture fixation <72h from admission
排除标准
- •has any additional injury or disability affecting mobility or affecting use of walking aids
- •has a pathological fracture (excluding osteoporotic fracture)
- •has an existing implant in study hip
- •has diagnosis of an immunosuppressive disorder
- •has an active infection, treated or untreated, systemic or at the site of the - has a condition that may interfere with the outcome of the study, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
- •has a BMI >40
- •has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia
- •is pregnant or plans to become pregnant during the course of the study
- •is a prisoner or is facing impending incarceration
- •in the opinion of the PI, has an emotional or neurological condition that would interfere with their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse
- •is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
- •is known to be at risk for lost to follow-up, or failure to return for scheduled visits
研究组 & 干预措施
Trigen Intertan
- Unique integrated interlocking screw and trapezoidal nail shape
- Resistance to femoral head rotation and cut-out
- Active compression through linear motion without rotation
- Single subtrochanteric lag screw option for stable fractures below lesser trochanter
- Preloaded cannulated set screw converts construct to fixed angle device
- Small proximal diameter of the nail promotes preservation of the lateral wall of the greater trochanter and gluteus medius tendon
- Clothespin tip for stress modulation in femoral shaft
- Potential for improved patient mobility and recovery
Manufactured by Smith & Nephew Inc., 1450 Brooks Road, Memphis, TN 38116, U.S.A.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up
干预措施: Trigen Intertan (Device)
Trigen Intertan
- Unique integrated interlocking screw and trapezoidal nail shape
- Resistance to femoral head rotation and cut-out
- Active compression through linear motion without rotation
- Single subtrochanteric lag screw option for stable fractures below lesser trochanter
- Preloaded cannulated set screw converts construct to fixed angle device
- Small proximal diameter of the nail promotes preservation of the lateral wall of the greater trochanter and gluteus medius tendon
- Clothespin tip for stress modulation in femoral shaft
- Potential for improved patient mobility and recovery
Manufactured by Smith & Nephew Inc., 1450 Brooks Road, Memphis, TN 38116, U.S.A.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up
干预措施: Post-Surgery Follow Up (Other)
Sliding Hip Screw
SHS is a generic term for a group of devices used for internal fixation of trochanteric hip fractures. Also known as Compression Hip Screw or Dynamic Hip Screw. All devices feature a lag screw inserted into the femoral neck and a side plate held in place by cortical screws inserted into the proximal femoral shaft.
Therapeutic effect is achieved by guided collapse, where the lag screw can slide in the barrel of the side plate which compresses the fracture as the patient begins to weight-bear.
Participating sites may use whichever brand of SHS is currently in use.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up
干预措施: Post-Surgery Follow Up (Other)
Sliding Hip Screw
SHS is a generic term for a group of devices used for internal fixation of trochanteric hip fractures. Also known as Compression Hip Screw or Dynamic Hip Screw. All devices feature a lag screw inserted into the femoral neck and a side plate held in place by cortical screws inserted into the proximal femoral shaft.
Therapeutic effect is achieved by guided collapse, where the lag screw can slide in the barrel of the side plate which compresses the fracture as the patient begins to weight-bear.
Participating sites may use whichever brand of SHS is currently in use.
Interventions:
Randomisation to either Trigen Intertan or Sliding Hip Screw, Post-Surgery Follow Up
干预措施: Sliding Hip Screw (Device)
结局指标
主要结局
Functional Independence Measure (motor portion)
时间窗: 8 weeks post-surgery
The FIM instrument is a basic indicator of severity of disability. Comprises 18 items assessed against a seven point ordinal scale, where the higher the score for an item, the more independently the patient is able to perform the tasks assessed by that item. Total scores range from 18 to 126. The items are divided into 13 Motor items and 5 Cognitive Items. The rating scale designates major graduations in behaviour from dependence to independence. The scale provides for the classification of individuals by their ability to carry out an activity independently, versus their need for assistance from another person or a device. If help is needed the scale assesses the degree of that need. Patient reported outcome.
次要结局
- Functional Independence Measure(12 weeks, 6 months and 12 months post-surgery)
- Get Up and Go Test(Discharge (estimated 2 weeks post-surgery) and 6 months post-surgery)
- Ambulatory Status Questionnaire(Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery)
- Radiographic Assessment (calculation of medialisation, shortening and tip-apex distance)(Pre-Op (Day prior to or day of surgery), immediately post-op and 6 months post-surgery)
- Residential Status Questionnaire(Pre-Op (Day prior to or day of surgery), Discharge (estimated 2 weeks post-surgery), 8 weeks, 12 weeks, 6 months and 12 months post-surgery)
- Modified Harris Hip Score(8 weeks, 12 weeks, 6 months and 12 months post-surgery)
- EQ-5D(8 weeks, 12 weeks, 6 months and 12 months post-surgery)
- Log of opioid medication administered(Daily from day 1 post-surgery to discharge (estimated 2 weeks post-surgery))