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

NCT03359278 | Unknown

• 1 other identifier: CSG-wrist201702
• Study Type: observational
• Target: 139
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Radius Fracture Distal

Keywords

distal radius fracture, sigmoid notch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ulnar wrist pain(VAS score)

  1 year after surgery

Other Outcomes (1)

• Union rate of ulnar styloid fracture

  1 year after surgery

Study Arms (1)

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

Interventions

open reduction and internal fixation PROCEDURE

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

Also known as: ORIF

open reduction and internal fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample, residents of Peking

You may qualify if:

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

You may not qualify if:

• old fracture, pathological fracture, open fracture
• bilateral distal radius fracture
• fracture of other parts of the wrist (excluding the ulnar styloid)

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (15)

• 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.

  PMID: 20961540 BACKGROUND

• 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.

  PMID: 4013706 BACKGROUND

• 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.

  PMID: 8683044 BACKGROUND

• 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.

  PMID: 11901379 BACKGROUND

• 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.

  PMID: 1123382 BACKGROUND

• 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.

  PMID: 12457345 BACKGROUND

• 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.

  PMID: 8724472 BACKGROUND

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

  PMID: 19302063 BACKGROUND

• 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.

  PMID: 20048089 BACKGROUND

• 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.

  PMID: 7229292 BACKGROUND

• 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.

  PMID: 16516740 BACKGROUND

• 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.

  PMID: 23221179 BACKGROUND

• 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.

  PMID: 19092013 BACKGROUND

• 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.

  PMID: 20079580 BACKGROUND

• 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.

  PMID: 26855837 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Tianbing Wang, Doctor

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Peng Zhang, Doctor

CONTACT

08601088326550; 52956255@qq.com

Yichong Zhang, Doctor

CONTACT

08601088326550; zhangyichong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of trauma and orthoppaedics

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 2, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 2, 2017

Record last verified: 2017-11