Effects of Ulnar Styloid and Sigmoid Notch Fractures on Postoperative Wrist Function of Distal Radius Fracture Patients

Effects of Ulnar Styloid and Sigmoid Notch Fractures on Postoperative Wrist Function of Patients With Distal Radius Fracture

To study the effects of ulnar styloid and sigmoid notch fractures on postoperative wrist function in patients with distal radius fracture

Study Overview

• Status: Unknown
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: open reduction and internal fixation

Detailed Description

Patients treated for distal radius fracture in the Department of Orthopedic Trauma at the People's Hospital of Peking University will be selected for outpatient follow-up. Evaluation was based on Sartiento's modification of the Gartland and Werley score. Efficacy was assessed with wrist pain as the focus.The follow-up time is one year after the operation。

• Study Type: Observational
• Enrollment (Anticipated): 139

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample, residents of Peking

Description

Inclusion Criteria:

1. unilateral distal radius fracture with or without ulnar styloid fracture, closed fracture
2. distal radius fracture repaired by internal fixation using a palmar plate
3. age of ≥18 years
4. integral clinical data, a postoperative follow-up period of ≥12 months
5. distal radius fracture with normal union
6. provision of informed consent after receiving an explanation of the purpose of this study

Exclusion Criteria:

1. old fracture, pathological fracture, open fracture
2. bilateral distal radius fracture
3. fracture of other parts of the wrist (excluding the ulnar styloid)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
open reduction and internal fixation; The volar approach was used for open reduction and internal fixation of distal radius fractures	Procedure: open reduction and internal fixation; The volar approach was used for open reduction and internal fixation of distal radius fractures; Other Names: ORIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sartiento's modification of the Gartland and Werley score	Sartiento's modification of the Gartland and Werley score included evaluation of residual deformity, subjective evaluation of pain, objective evaluation of range of wrist motion and grip strength, and evaluation of complications of arthritis, neurological symptoms, and finger dysfunction. Efficacy was judged as excellent, good, fair, or poor, and the sum of the above scores was calculated (excellent, 0-2 points; good, 3-8 points; fair, 9-20 points; and poor, ≥21 points)	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ulnar wrist pain(VAS score)	Evaluation of ulnar wrist pain based on VAS score.Visual Analogue Scale/Score:A cross line of 10 cm on the paper, 0 at one end of the horizontal line, is painless; the other end is 10, indicating a sharp pain; the middle part indicates a different degree of pain.	1 year after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union rate of ulnar styloid fracture	Union rate of ulnar styloid fracture:The fracture line of the ulnar styloid process disappeared, the fracture healed well, there was no obvious pain in the wrist and no abnormal activity.	1 year after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: Tianbing Wang, Doctor, Peking University People's Hospital

Publications and helpful links

General Publications

• Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.
• Kim JK, Yun YH, Kim DJ, Yun GU. Comparison of united and nonunited fractures of the ulnar styloid following volar-plate fixation of distal radius fractures. Injury. 2011 Apr;42(4):371-5. doi: 10.1016/j.injury.2010.09.020. Epub 2010 Oct 20.
• Bengner U, Johnell O. Increasing incidence of forearm fractures. A comparison of epidemiologic patterns 25 years apart. Acta Orthop Scand. 1985 Apr;56(2):158-60. doi: 10.3109/17453678508994345.
• Baratz ME, Des Jardins Jd, Anderson DD, Imbriglia JE. Displaced intra-articular fractures of the distal radius: the effect of fracture displacement on contact stresses in a cadaver model. J Hand Surg Am. 1996 Mar;21(2):183-8. doi: 10.1016/s0363-5023(96)80098-0.
• Orbay JL, Fernandez DL. Volar fixation for dorsally displaced fractures of the distal radius: a preliminary report. J Hand Surg Am. 2002 Mar;27(2):205-15. doi: 10.1053/jhsu.2002.32081.
• May MM, Lawton JN, Blazar PE. Ulnar styloid fractures associated with distal radius fractures: incidence and implications for distal radioulnar joint instability. J Hand Surg Am. 2002 Nov;27(6):965-71. doi: 10.1053/jhsu.2002.36525.
• Hauck RM, Skahen J 3rd, Palmer AK. Classification and treatment of ulnar styloid nonunion. J Hand Surg Am. 1996 May;21(3):418-22. doi: 10.1016/S0363-5023(96)80355-8.
• Tsai PC, Paksima N. The distal radioulnar joint. Bull NYU Hosp Jt Dis. 2009;67(1):90-6.
• Kim JK, Koh YD, Do NH. Should an ulnar styloid fracture be fixed following volar plate fixation of a distal radial fracture? J Bone Joint Surg Am. 2010 Jan;92(1):1-6. doi: 10.2106/JBJS.H.01738.
• Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.
• Haugstvedt JR, Berger RA, Nakamura T, Neale P, Berglund L, An KN. Relative contributions of the ulnar attachments of the triangular fibrocartilage complex to the dynamic stability of the distal radioulnar joint. J Hand Surg Am. 2006 Mar;31(3):445-51. doi: 10.1016/j.jhsa.2005.11.008.
• Kramer S, Meyer H, O'Loughlin PF, Vaske B, Krettek C, Gaulke R. The incidence of ulnocarpal complaints after distal radial fracture in relation to the fracture of the ulnar styloid. J Hand Surg Eur Vol. 2013 Sep;38(7):710-7. doi: 10.1177/1753193412469582. Epub 2012 Dec 6.
• Zenke Y, Sakai A, Oshige T, Moritani S, Nakamura T. The effect of an associated ulnar styloid fracture on the outcome after fixation of a fracture of the distal radius. J Bone Joint Surg Br. 2009 Jan;91(1):102-7. doi: 10.1302/0301-620X.91B1.21026.
• Buijze GA, Ring D. Clinical impact of United versus nonunited fractures of the proximal half of the ulnar styloid following volar plate fixation of the distal radius. J Hand Surg Am. 2010 Feb;35(2):223-7. doi: 10.1016/j.jhsa.2009.10.035. Epub 2010 Jan 15.
• Vitale MA, Brogan DM, Shin AY, Berger RA. Intra-articular Fractures of the Sigmoid Notch of the Distal Radius: Analysis of Progression to Distal Radial Ulnar Joint Arthritis and Impact on Upper Extremity Function in Surgically Treated Fractures. J Wrist Surg. 2016 Mar;5(1):52-8. doi: 10.1055/s-0035-1570742. Epub 2016 Jan 6.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 26, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: distal radius fracture, sigmoid notch
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: CSG-wrist201702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No