Single Impact Versus Dual Implant Fixation of Distal Femur Extra Articular and Complete Articular Fractures in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Number of Unions
研究概览
简要总结
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
详细描述
Fractures of the distal femur are severe and common injuries sustained by older adults. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to activities of daily living and impacts quality of life. Despite numerous studies of a variety of different surgical treatment strategies, the incidence of nonunion remains high. Therefore, any novel strategy to reduce the risk of nonunion and accelerate return to activities after distal femur fracture warrants rigorous study. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 55 years
- •Surgically treated displaced distal femur extra articular or complete articular fractures
排除标准
- •Patients with injury features that preclude treatment with 2 implants
- •Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
- •Body Mass Index (BMI) > 40
- •Injury due to ground level fall
- •Patient that speaks neither English or Spanish
- •Patients with multisystem injuries that could preclude return to work
- •< 55 years of age
研究组 & 干预措施
Single Implant Fixation
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.
干预措施: Single Implant Fixation (Procedure)
Dual Implant Fixation
Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care.
干预措施: Dual Implant Fixation (Procedure)
结局指标
主要结局
Number of Unions
时间窗: 6-week, 3, 6, 12 months
Union, as determined by the treating surgeon, will be assessed via radiographs and documented as a dichotomous outcome (yes/no), and time to union will also be captured. Nonunion will be captured via surgeon diagnosis or return to the operating room for nonunion treatment.
Total Surgical Time - Reoperations
时间窗: 6-week, 3, 6, 12 months
The total surgical time during any reoperations will be collected from the medical record.
Number of Reoperations
时间窗: 6-week, 3, 6, 12 months
Details regarding reoperations will also be collected, whether or not the operation results in an inpatient admission.
次要结局
- Number of Resource Utilizations(6-week, 3, 6, 12 month)
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores(Month 12)
- Time to Walking Without an Assistive Device(6-week, 3, 6, 12 months)
- Prescribed Weight Bearing Status(6-week, 3, 6, 12 months)
- Fear of Movement -Tampa Scale for Kinesiophobia (TSK) Scores(6-week, 3, 6, 12 months)
- Health Related Quality of Life - Patient-Reported Outcomes Measurement Information System (PROMIS) Scores(6-week, 3, 6, 12 months)
- Global Health Status - Veterans RAND 12 Item Health Survey (VR12) Scores(6-week, 3, 6, 12 months)
- Work Productivity and Activity Impairment Questionnaire Scores(6-week, 3, 6, 12 months)
- Numeric Pain Rating(6-week, 3, 6, 12 months)
- Pain Inventory (BPI)(6-week, 3, 6, 12 months)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference(6-week, 3, 6, 12 months)
- Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) Classification(1 year)
- Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS)(1 year)
- Geriatric Depression Scale(6-week, 3, 6, 12 months)
- Morphine Milligram Equivalents (MME)(6-week, 3, 6, 12 months)
- Total Surgical Time - Index Surgery(Baseline)
- Total Hospital Days(Baseline, 6-week, 3, 6, 12 months)
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores(Week 6)
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores(Month 3)
- Return to Work - International Physical Activity Questionnaire (IPAQ) Scores(Month 6)