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

Radius Fracture Distal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03359278
• Other study ID #: CSG-wrist201702
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: November 30, 2017
• Start date: April 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Peng Zhang, Doctor
• Phone: 08601088326550
• Email: 52956255[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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。

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 139
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

Procedure:
• open reduction and internal fixation
The volar approach was used for open reduction and internal fixation of distal radius fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (15)

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. — View Citation

Bengnér 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. — View Citation

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. — View Citation

Hauck RM, Skahen J 3rd, Palmer AK. Classification and treatment of ulnar styloid nonunion. J Hand Surg Am. 1996 May;21(3):418-22. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Krämer 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. — View Citation

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. — View Citation

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. — View Citation

Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. — View Citation

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. — View Citation

Tsai PC, Paksima N. The distal radioulnar joint. Bull NYU Hosp Jt Dis. 2009;67(1):90-6. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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