Distal Radial Fractures in the Late Middle Aged: Surgical or Conservative Treatment - A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Recruitment and eligibility rates
研究概览
简要总结
Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of the bones making up the wrist joint, and is typically the site of injury in a broken wrist. Methods of treating a broken radius include placing the wrist in a cast for 6 weeks (conservative management) or receiving surgery. Surgery allows for earlier movement of the wrist and return to activity, while being placed in a cast is less invasive than surgery.
Surgery to fix these fractures has become more common; however there is little agreement about who should receive surgery and who should be placed in a cast to heal. The goal of this study is to compare outcomes between people aged 55-70 who have broken their wrist and had surgery, and those who received a cast.
Procedures: Participants in this study will be randomly assigned to one of two study groups within 1 week of injury at their first clinic visit with the surgeon.
Patients in Group A (surgical management) will continue with casting for a total of 6 weeks, as indicated by the surgeon.
Patients in Group B (conservative management) will receive surgery, and the attending surgeon will determine the best fracture fixation method for the wrist.
The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after the initial injury. At each assessment, the wrist will be examined and participants will be asked to fill in some questionnaires about health, pain, wrist function, and satisfaction with the wrist. An X-ray will also be performed on the wrist to assess bone healing. Information from each visit will be used to determine how participants are doing and to compare the 2 study groups.
详细描述
BACKGROUND
Distal radius fractures (DRF) are the most common upper extremity fractures in late middle-aged patients. This injury creates significant disability rendering a person without full use of the affected hand and wrist for 6 weeks or more with potential long-term consequences of post-traumatic wrist arthritis and contracture. Over the past 20 years, surgical management of DRF has increased substantially. Despite the frequency of these fractures, there is little comparative evidence to guide surgical decision-making for this population.
Although surgical management improves radiographic outcomes, it does not appear that radiographic outcomes correlate well with patient reported outcomes (pain and function). As there are significant health resource implications of surgical versus conservative management, it is imperative that we determine when operative fixation is needed. Further, as our population is aging, the number of patients with DRF will increase substantially in the late to middle-aged and elderly adults.
For subjects under 55 years of age, surgical management is often undertaken to allow early mobility and facilitate return to work and activity, even in the presence of equivocal clinical outcomes between management approaches. Conversely, in those who are older than 70 years, conservative management is more common due to lower patient demands.
However, the American Academy of Orthopedic Surgeons issued clinical practice guidelines that could not make evidence based treatment recommendations for patients aged 55 to 70 years with DRFs. Thus, there is no current available evidence comparing patient outcomes between surgical and conservative management in this age group. The overall goal of RIST will be to compare outcomes between patients aged 55-70 years who receive surgical or conservative management. Our primary outcome will be a clinical measure (patient-reported or performance-based) rather than radiographic alignment.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 55-70 and have had a distal radial fracture
- •The following radiographic findings before reduction: dorsal angulation ≤30 degrees, ulnar shortening ≤5 mm relative to the contralateral side (subjects will have contralateral wrist xrays), articular step ≤2 mm after initial post reduction and gap ≤5 mm
排除标准
- •patients with volarly displaced intra and extra articular fractures (Barton and Smith's)
- •radiocarpal subluxation or dislocation
- •open fractures
- •ipsilateral upper-extremity injuries
- •bilateral or multiple traumas
- •previous injury to the contralateral wrist
- •those deemed not suitable for surgical management (as indicated and documented by surgeon and research coordinator)
结局指标
主要结局
Recruitment and eligibility rates
时间窗: 1 year
次要结局
- Visual Analogue Scale (VAS) for cosmesis(6 weeks, 3 months, 6 months, 12 months)
- Visual Analogue Scale (VAS) for pain(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Grip Strength (Hand held dynamometer)(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Patient Rated Wrist-Evaluation (PRWE) questionnaire(baseline, 6 weeks, 3 months, 6 months, and 12 months)
- Range of Motion (Goniometry)(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Radiographic measures (Doral angulation, ulnar shortening, articular steps and gaps)(baseline, 6 weeks, 3 months, 6 months, 12 months)