ClinicalTrials.gg
Status unknownNCT03359278Updated Dec 2, 2017

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

An observational study in Radius Fracture Distal, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
139
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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。

02

Conditions studied

  • Radius Fracture Distal

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Keywords

  • distal radius fracture, sigmoid notch
03

In context

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.

This study's planned enrollment of 139 is above the median of 100 across 53 observational studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

community sample, residents of Peking

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 after receiving an explanation of the purpose of this study

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
139 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Procedureopen reduction and internal fixation

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

    Also known as: ORIF

06

What researchers measure

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)

    Time frame: 1 year after surgery

Secondary outcomes

  1. 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.

    Time frame: 1 year after surgery

Other outcomes

  1. 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.

    Time frame: 1 year after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 20961540 ↗
  • 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. PubMed 4013706 ↗
  • 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. PubMed 8683044 ↗
  • 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. PubMed 11901379 ↗
  • 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. PubMed 1123382 ↗
  • 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. PubMed 12457345 ↗
  • 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. PubMed 8724472 ↗
  • Tsai PC, Paksima N. The distal radioulnar joint. Bull NYU Hosp Jt Dis. 2009;67(1):90-6. PubMed 19302063 ↗
  • 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. PubMed 20048089 ↗
  • 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. PubMed 7229292 ↗
  • 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. PubMed 16516740 ↗
  • 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. PubMed 23221179 ↗
  • 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. PubMed 19092013 ↗
  • 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. PubMed 20079580 ↗
  • 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. PubMed 26855837 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Apr 2020, 24 months later.

Of 20 observational studies under Wrist Fractures, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 63. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2017
First posted
Dec 2, 2017
StartEst.
Apr 1, 2018
Primary completionEst.
Apr 1, 2020
CompletionEst.
Apr 1, 2020
Last update
Dec 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03359278
Responsible party
pengzhang (department of trauma and orthoppaedics, Peking University People's Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
Apr 1, 2018 (estimated)
Primary completion
Apr 1, 2020 (estimated)
Completion
Apr 1, 2020 (estimated)
Last update
Dec 2, 2017

Study contacts

Peng Zhang, Doctor
Contact
52956255@qq.com
08601088326550
Yichong Zhang, Doctor
Contact
zhangyichong@163.com
08601088326550
Tianbing Wang, Doctor
study director · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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