A Prospective, Randomised Controlled Pilot Trial Of Wrist Joint Haematoma Washout As An Adjunct To Volar Plating In Intra-articular Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean difference between QuickDASH scores of both treatment arms at 3 months
研究概览
简要总结
Intra-articular fractures of the distal radius are common in urban populations and result in significant morbidity in terms of time away from work. Volar plating of the distal radius is a commonly used mode of surgical fixation of this fracture. The joint haematoma resulting from the fracture has been hypothesized to contribute to the post-injury disability. As such, this study aims to examine if the evacuation of the haematoma during volar plating results in superior functional outcomes at three months post surgery.
详细描述
Distal radius fractures have an incidence of up to 50% of all fractures, with up to two thirds being intra-articular fractures. While most fractures treated with a variety of methods achieve satisfactory patient reported outcomes at one year post treatment, patients experience pain and functional impairment up to 3 and 6 months post treatment. Open reduction and internal fixation using volar plates is one popular mode of treatment. It is relatively widely available and allows almost immediate post operative mobilisation and rehabilitation.
One theory which could explain the delay in functional recovery is the persistence of the intra-articular haematoma. The evacuation of this haematoma may be partly responsible for the satisfactory results published by authors who perform wrist arthroscopy assisted distal radius fixation.
In our literature review, it is not routine to evacuate this haematoma during conventional volar plating of the distal radius. As such, we aim to study if the evacuation of the haematoma in conjunction with volar plating confers functional benefits in the short term, particularly at 3 months post surgery.
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 (Participant)
盲法说明
Participants are blinded, since the study procedure will be performed via the incision for the main surgery. Thus no external (wound) evidence of the participant's allocation will be visible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients of either sex who sustain closed fractures of the distal end radius involving the articular surface, between the ages of 18 and 65
- •The fracture pattern is of an unacceptable morphology as defined by the following radiographic parameters according to the 2009 American Academy of Orthopaedic Surgeons (AAOS) Clinical Guidelines (Lichtmann, Bindra et al. 2010):
- •>3 mm radial shortening >10° dorsal tilt >2 mm articular displacement The patient has been planned to undergo VLPF Femalepatientswilleitherbe Post-menopausal Surgically sterile If of childbearing age, must have a negative urine pregnancy test at screening and at randomisation. Pregnancy tests will be repeated during each visit.
排除标准
- •Open fractures Associated fractures around the wrist (e.g. carpal bones, metacarpals, phalanges) requiring different or additional methods of fracture fixation and stabilisation Polytraumatised patients Compartmentsyndromeoftheforearmorhand Neurovascular injury of the ipsilateral limb Concomitantfractureoftheipsilateraland/orcontralateralupperlimbwhichmayimpede post-operative rehabilitation Fractures exceeding 14 days duration during time of first presentation
- •Pre-existing conditions such as:
- •Inflammatory arthritides Connective tissue diseases Diseases of bone metabolism (except osteoporosis) Prior malunited/nonunited fractures of the ipsilateral limb Pregnancy Patients unfit for surgery due to poor general condition Inability or unwillingness to provide written consent. Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
研究组 & 干预措施
Treatment
Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
干预措施: Wrist joint haematoma washout (Procedure)
Treatment
Participants who will undergo both volar locking plate fixation of the distal radius and the study procedure (wrist joint haematoma washout)
干预措施: Volar locking plate insertion of the distal radius (Procedure)
Placebo
Participants who will undergo volar locking plate fixation of the distal radius only
干预措施: Volar locking plate insertion of the distal radius (Procedure)
结局指标
主要结局
Mean difference between QuickDASH scores of both treatment arms at 3 months
时间窗: 3 months
A patient reported outcome using the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score. This is a patient reported outcome score, which consists of 11 questions. A minimum of 10 must be answered for the score to be valid. The score out of 11 is then calculated as a percentage, with higher numbers indicating worse disability.
次要结局
- Mean difference between QuickDASH scores of both treatment arms at 2 weeks, 6 weeks, and 6 months(2 weeks, 6 weeks and 6 months)
- Mean difference between the visual analogue scores of both groups(2 weeks, 6 weeks, 3 months and 6 months)
- Mean difference between the range of motion of the wrist of both groups(2 weeks, 6 weeks, 3 months and 6 months)
- Mean difference between rate of complications of both groups(6 months)
- Mean difference in time to radiographic fracture union of both groups(6 months)
- Mean difference of rate of improvement of QuickDASH scores between groups across 6 months of follow up(6 months)
- Mean difference between the grip strength of both groups(2 weeks, 6 weeks, 3 months and 6 months)
研究者
Ong Jo Hann
Orthopaedic Trainee
University of Malaya