Clinical Outcomes Comparison of Distal Radius Fractures Between Two Conservative Treatment Methods: Below-Arm Cast Versus Reverse Sugar Tong Splint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Fracture Healing Outcome
研究概览
简要总结
There are many conservative treatment methods, including below arm cast, above arm cast, and sugar tong splint that aim to obtain maximum functional, clinical, and radiological results There are no clear indications with regard to the best treatment including conservative or surgical methods for the different fracture subtypes in distal radius fracture. The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.
详细描述
This study was conducted at a single Orthopedics and Traumatology emergency department center between April 2017 and March 2019. A two-arm, parallel-group, prospective randomized trial was conducted to compare below-arm cast (BAC) and reverse sugar tong (RST) (described below) treatment of DRF.
Overall, 231 patients diagnosed with distal radius fracture in the emergency department received prospective treatment.
Inclusion criteria: Patients aged >18 years and with distal radius fracture type A and B (who presented within 10 days of the injury) were considered for inclusion.
Exclusion criteria: Patients with AO type C distal radius fractures (treated surgically), type 2 and 3 open fractures (according to Gustilo classification), previous hand or wrist surgery, fractures in the concomitant side of the upper extremities, associate carpal fracture, deformity on same extremity, pathological fractures, and cognitive deficit that does not allow the patient to understand the functional evaluation were excluded from this study. Lastly, patients who did not return for a follow-up visit at the end of the cast or splint treatment were also excluded.
Patient selection and treatment methods Sample Size: The sample size was calculated based on a 15-20% difference in complication rate between the two treatment groups, an alpha level of 5% and a power of 80%. Consequently, each group shall at least consist of 55 participants. We considered an extra 20% who loss of follow-up or loss of reduction and surgery may require for balancing sample size. With expectation of dropouts70 patients per group were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged >18 years,
- •with distal radius fracture type A and B (who presented within 10 days of the injury)
排除标准
- •Patients with AO type C distal radius fractures (treated surgically),
- •type 2 and 3 open fractures (according to Gustilo classification),
- •previous hand or wrist surgery,
- •fractures in the concomitant side of the upper extremities,
- •associate carpal fracture, deformity on the same extremity,
- •pathological fractures,
- •cognitive deficit that does not allow the patient to understand the functional evaluation
- •patients who did not return for a follow-up visit at the end of the cast or splint treatment
结局指标
主要结局
Fracture Healing Outcome
时间窗: 6th week
All patients were evaluated fracture healing with x-ray view which assessment of radiological union by observing the presence of bridging callus or the obscuration of the fracture line.
次要结局
- Health relaated quality of life(6th week)
- Rate of Complications Outcomes(1st week, 3rd week and 6th week)
- Functional Outcomes(12th week and 1st year)
研究者
Savaş Çamur
Principal Investigator
Umraniye Education and Research Hospital