Intraoperativ Testing of Scapholunate Instability in Radius Fracture

NCT04631003 | Unknown

• 1 other identifier: 2019-02146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radius; Dislocation Distal; Scapholunate Dissociation

Keywords

Scapholunary Instability; Distal, intra-articulare Radius Fracture; Dynamic Functional Testing; Arthro-CT; Scapholunate Dissociation; Scapholunate Advanced Collapse

Outcome Measures

Primary Outcomes (1)

• Dynamic Functional Testing

  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.

  Through study completion, an average of 1 year

Study Arms (1)

Dynamic testing

OTHER

There are only one arm in this study. All patients get the same diagnostics and therapy. The preoperative assessments consist of an arthroCT of the wrist as well as the collection of demographic data, accident mechanism, medication intake, etc. within the scope of the usual medical history on the emergency ward. With the arthro-CT, in addition to the fracture balance, the proof of a possible rupture of the scapholunary tape apparatus takes place. The dynamic determination of the scapholunary instability takes place during the osteosynthesis of the radius fracture. With the dynamic functional test, the change of the scapholunary distance is assessed by illumination by movement of the wrist from the radial abduction into the ulnar abduction, before and after the execution of the osteosynthesis of the distal radius fracture. Subsequently, the results of the scapholunary dissociation of the arthro-CT are checked with the results of the intraoperative dynamic test for correlation.

Diagnostic Test: dynamic functional testing

Interventions

dynamic functional testing DIAGNOSTIC_TEST

First, with an arthroCT of the wrist by intraarticular injection of contrast agent, a possible scaphulonary band lesion is detected. The surgeon does not yet know the findings of the possible ligament injury at this time, but he can assess the fracture in the CT. Subsequently, a dynamic functional test of the scapholunary distance is carried out intraoperatively under investigation with the modified Watson test before and after performing the osteosynthesis. For this purpose, the wrist is intraoperatively brought under pull on the thumb from a radial abduction into an ulnarabduction. In the presence of a scapholunary instability, a change in the distance of the scapholunary joint gap is shown here under illumination. Now the surgeon receives the finding of the Arthro-CT regarding an existing ligament injury. If necessary, this is treated in the same anaesthetic with a band seam and ossary transfixation.

Dynamic testing

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spital Davos AG: lead
• AO Research Institute Davos: collaborator

Study Sites (1)

Spital Davos AG

Davos Platz, Kanton Graubünden, 7270, Switzerland

RECRUITING

Related Publications (15)

• Chim H, Moran SL. Wrist essentials: the diagnosis and management of scapholunate ligament injuries. Plast Reconstr Surg. 2014 Aug;134(2):312e-322e. doi: 10.1097/PRS.0000000000000423.

  PMID: 25068352 BACKGROUND

• Forward DP, Lindau TR, Melsom DS. Intercarpal ligament injuries associated with fractures of the distal part of the radius. J Bone Joint Surg Am. 2007 Nov;89(11):2334-40. doi: 10.2106/JBJS.F.01537.

  PMID: 17974874 BACKGROUND

• Geissler WB, Freeland AE, Savoie FH, McIntyre LW, Whipple TL. Intracarpal soft-tissue lesions associated with an intra-articular fracture of the distal end of the radius. J Bone Joint Surg Am. 1996 Mar;78(3):357-65. doi: 10.2106/00004623-199603000-00006.

  PMID: 8613442 BACKGROUND

• Gunal I, Ozaksoy D, Altay T, Satoglu IS, Kazimoglu C, Sener M. Scapholunate dissociation associated with distal radius fractures. Eur J Orthop Surg Traumatol. 2013 Dec;23(8):877-81. doi: 10.1007/s00590-012-1093-x. Epub 2012 Oct 16.

  PMID: 23412224 BACKGROUND

• Kitay A, Wolfe SW. Scapholunate instability: current concepts in diagnosis and management. J Hand Surg Am. 2012 Oct;37(10):2175-96. doi: 10.1016/j.jhsa.2012.07.035.

  PMID: 23021178 BACKGROUND

• Lindau T, Arner M, Hagberg L. Intraarticular lesions in distal fractures of the radius in young adults. A descriptive arthroscopic study in 50 patients. J Hand Surg Br. 1997 Oct;22(5):638-43. doi: 10.1016/s0266-7681(97)80364-6.

  PMID: 9752922 BACKGROUND

• Mitsuyasu H, Patterson RM, Shah MA, Buford WL, Iwamoto Y, Viegas SF. The role of the dorsal intercarpal ligament in dynamic and static scapholunate instability. J Hand Surg Am. 2004 Mar;29(2):279-88. doi: 10.1016/j.jhsa.2003.11.004.

  PMID: 15043902 BACKGROUND

• Mrkonjic A, Lindau T, Geijer M, Tagil M. Arthroscopically diagnosed scapholunate ligament injuries associated with distal radial fractures: a 13- to 15-year follow-up. J Hand Surg Am. 2015 Jun;40(6):1077-82. doi: 10.1016/j.jhsa.2015.03.017. Epub 2015 Apr 30.

  PMID: 25936737 BACKGROUND

• Pilny J, Kubes J, Hoza P, Mechl M, Visna P. [Scapholunate instability of the wrist following distal radius fracture]. Acta Chir Orthop Traumatol Cech. 2007 Feb;74(1):55-8. Czech.

  PMID: 17331455 BACKGROUND

• Prommersberger KJ, Muhldorfer-Fodor M, Kalb K, Schmitt R, van Schoonhoven J. [Scapholunate lesions]. Unfallchirurg. 2014 Aug;117(8):723-37; quiz 738-9. doi: 10.1007/s00113-014-2621-4. German.

  PMID: 25116013 BACKGROUND

• Richards RS, Bennett JD, Roth JH, Milne K Jr. Arthroscopic diagnosis of intra-articular soft tissue injuries associated with distal radial fractures. J Hand Surg Am. 1997 Sep;22(5):772-6. doi: 10.1016/S0363-5023(97)80068-8.

  PMID: 9330132 BACKGROUND

• Short WH, Werner FW, Green JK, Masaoka S. Biomechanical evaluation of the ligamentous stabilizers of the scaphoid and lunate: Part II. J Hand Surg Am. 2005 Jan;30(1):24-34. doi: 10.1016/j.jhsa.2004.09.015.

  PMID: 15680552 BACKGROUND

• Sun GTW, MacLean SBM, Alexander JJ, Woodman R, Bain GI. Association of scapholunate dissociation and two-part articular fractures of the distal radius. J Hand Surg Eur Vol. 2019 Jun;44(5):468-474. doi: 10.1177/1753193419826490. Epub 2019 Feb 6.

  PMID: 30727814 BACKGROUND

• Suzuki D, Ono H, Furuta K, Katayama T, Akahane M, Omokawa S, Tanaka Y. Comparison of scapholunate distance measurements on plain radiography and computed tomography for the diagnosis of scapholunate instability associated with distal radius fracture. J Orthop Sci. 2014 May;19(3):465-70. doi: 10.1007/s00776-014-0533-3. Epub 2014 Jan 29.

  PMID: 24473829 BACKGROUND

• Tang JB, Shi D, Gu YQ, Zhang QG. Can cast immobilization successfully treat scapholunate dissociation associated with distal radius fractures? J Hand Surg Am. 1996 Jul;21(4):583-90. doi: 10.1016/S0363-5023(96)80007-4.

  PMID: 8842947 BACKGROUND

Study Officials

• Michael Villiger

  Spital Davos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Genthner

CONTACT

+41 814148118; agenthner@spitaldavos.ch

Hans-Curd Frei

CONTACT

+41 814148118; hfrei@spitaldavos.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Davos Sports & Health

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 16, 2020
• Study Start: October 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)