跳至主要内容
临床试验/NCT04631003
NCT04631003Unknown不适用

Pilot Study for a Dynamic Testing for Intraoperative Diagnosis of Scapholunate Instability in Patients With a Concurrent Distal, Intra Articular Radius Fracture - A Prospective Clinical Trial

Spital Davos AG2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Dynamic Functional Testing

研究概览

简要总结

Ligamental side injuries in distal radius fractures are not uncommon, but diagnosis is often difficult. Diagnosis with the simultaneous presence of a fracture is not very reliable and usually highly subjective.

5-64% of radius fractures are accompanied by injuries of the scapholunary ligament (SL). Intra-articular radius fractures have a significantly higher prevalence for SL dissociation, due to a greater energy transfer to the hand roots. In 5-10% of cases, distal, intra-articular radius fractures are associated with complete ruptures of the dorsal scapholunary band. The number of untreated SL band lesions in distal radius fractures is largely unknown.

If left untreated, scapholunary ligament lesions, with the simultaneous presence of a rupture of the dorsal ligament, (DIC) can lead to symptomatic carpal instability, therefore the correct diagnosis and adequate therapy is necessary even in the presence of a distal radius fracture.

Through the band ruptures, both the Os lunatum and the Os scaphoideum experience irregular motion. This leads to Dorsal Intercalated Segment Instability (DISI) and is reflected by the flexion of the os scaphoideum and the extension of the os lunatum radiologically in the lateral uptake with an increase of the scapholunary angle > 60° (usually maximum 45)° and the radioscaphoidal angle >15°.

An incorrect use can lead to the development of SLAC-wrist (Scapho-Lunate Advanced Collapse) over years, this risk should be reduced if possibel by recognizing the original injury.

With regard to this problem, we would like to establish a radiological, dynamic functional test, allowing scapholunary ligament lesions in distal radius fractures to be diagnosed intraoperatively.

详细描述

Radius fractures are the most common fractures in adulthood and account for approximately 17.5% of all fractures. The most common distal radius fractures are approximately 57-66% extra-articular (AO type A), followed by completely articular fractures (AO type C) with 25-35% and the least rare partial articular fractures (AO type B) with 9-15%.

The fracture mechanism of distal radius fractures is in most cases a fall on the extended wrist, less often a high-energy trauma. It is not uncommon for there to be additional accompanying ligamental injuries, which are easily overlooked.

5-64% of intraarticular radius fractures are accompanied by injuries of the scapholunary ligament. However, most of these studies are carried out in smaller series, with only one exception. A scapholunary band lesion can occur in isolation or in combination with a distal radius fracture, scaphoid fracture or perilunary luxation. The prevalence of this ligament injury has not yet been sufficiently studied. Acute scapholunary ligament damage accompanying injury to a distal radius fracture, clinical testing of instability by means of the Watson provocation test is not possible due to pain. Thus, scapholunary dissociation is often initially overlooked. Additional later examinations by means of MRI or arthroscopy are necessary to diagnose the missed ligamentary injuries.

In 5-10% of cases, intraarticular radius fractures are associated with complete ruptures of the dorsal scapholunary band, which leads to symptomatic carpal instability with the simultaneous presence of a rupture of the dorsal ligamentum intercarpale (DIC). The number of untreated SL band lesions in distal radius fractures is largely unknown.

A scapholunary band lesion can be represented in different degrees of severity, depending on the still preserved portion of the scapholunary ligament and the surrounding extrinsical ligaments. Partial ruptures only lead to pain during movement and result in a slight restriction of scaphoid mobility. A scapholunary complete rupture, on the other hand, leads to a dissociation of ossa scaphoideum and lunatum, resulting in a Dorsal Intercalated Segment Instability (DISI). DISI malposition in turn leads in the long run to wrist osteoarthritis, called SLAC Wrist, with secondary development of osteoarthritis. The development of the full disease takes 10-20 years. The development of a SLAC Wrist can be counteracted preventively in which a scapholunary instability - also within the framework of a radius fracture - is detected at an early stage and correctly stabilized. However, the clinical relevance and the recommended treatment of scapholunary band rupture has not yet been definitively clarified.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a distal radius fracture that reaches into the wrist joint
  • Age >16 and <80 years
  • Signed informed consent
  • Carrying out surgery of the radius fracture at Hospital of Davos

排除标准

  • Age <16 and >80 years
  • Contraindications for computer tomography or contrast agents
  • Undislocated distal radius fractures that do not need meet criteria of stabilization with a plate (surgery)
  • Serious illness that does not allow surgery
  • Pregnancy
  • Use of strong blood-thinning medications
  • Severe coagulation disorder

结局指标

主要结局

Dynamic Functional Testing

时间窗: Through study completion, an average of 1 year

Change in the distance between Os scaphoideum and Os lunatum in the dynamic function test under illumination in distal, intraarticular radius fracture and thus evidence of scapholunal instability. Intraoperatively, the scapholunary instability is investigated by means of a provocation test under illumination with the image converter. For this purpose, the wrist is moved from a radial abduction to an ulnarabduction under tension on the thumb in the ap recording. In the presence of a scapholunary dissociation, in the sense of an unstable band rupture, an increase in the scapholunary distance is shown. The obtained statement regarding a scapholunary dissociation by the function test must be verified with an arthro-CT.

次要结局

未报告次要终点

研究者

发起方
Spital Davos AG
申办方类型
Network
责任方
Principal Investigator
主要研究者

Dr. Michael Villiger

Co-Director of Davos Sports & Health

Spital Davos AG

研究点 (2)

Loading locations...

相似试验

Intraoperativ Testing of Scapholunate Instability in... | 临床试验