Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03359278
Other study ID # CSG-wrist201702
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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 allClick 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
See also
  Status Clinical Trial Phase
Completed NCT03311633 - Complications in Distal Radius Fracture N/A
Recruiting NCT05015556 - Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures. N/A
Recruiting NCT05974254 - Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation N/A
Recruiting NCT04549441 - Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery
Terminated NCT05655130 - Distal Radius Steroid Phase 1
Not yet recruiting NCT05580848 - Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures N/A
Withdrawn NCT04359017 - Systemic Absorption of Lidocaine After Hematoma Block Phase 4
Withdrawn NCT04135768 - A Study Examining The Effect Of Wrist Joint Haematoma Washout As An Adjunct Procedure To Plating Of The Distal Radius In Fractures Of The Distal Radius Involving The Wrist Joint N/A
Completed NCT03716661 - Operative vs. Conservative Treatment of Distal Radius Fractures N/A
Recruiting NCT06046404 - Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department N/A
Completed NCT03186963 - Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures N/A
Not yet recruiting NCT05318729 - Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures N/A
Completed NCT03468023 - Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial N/A
Completed NCT05346926 - Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures N/A
Recruiting NCT05008029 - Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius N/A
Completed NCT01497080 - Distal Radius Fracture Prospective Database 50-80 Years Old N/A
Not yet recruiting NCT05631314 - Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (LADON Radius)
Completed NCT05421000 - WALANT in Distal Radius Fracture Osteosynthesis N/A
Recruiting NCT05371938 - Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up N/A