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Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

This study is ongoing, but not recruiting participants.
AO foundation
Information provided by (Responsible Party):
Jesse B. Jupiter, MD, Massachusetts General Hospital Identifier:
First received: August 30, 2010
Last updated: October 3, 2016
Last verified: October 2016

August 30, 2010
October 3, 2016
August 2010
December 2017   (Final data collection date for primary outcome measure)
grip strength [ Time Frame: 3, 6, 12 months ]
Same as current
Complete list of historical versions of study NCT01193010 on Archive Site
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Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Extraarticular Distal Radius Malunion
  • Procedure: Computer-Assisted Surgical Planning
    Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
  • Procedure: distal radius osteotomy
    In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy.
  • Active Comparator: Control
    Surgery without computer-assisted planning.
    Intervention: Procedure: distal radius osteotomy
  • Experimental: Computer-Assisted Surgical Planning
    Intervention: Procedure: Computer-Assisted Surgical Planning
Leong NL, Buijze GA, Fu EC, Stockmans F, Jupiter JB; Distal Radius Malunion (DiRaM) collaborative group.. Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Extraarticular distal radius malunion requiring surgery
  • Adult patient (> 18 yo)
  • Fluent in English

Exclusion Criteria:

  • Pregnant patient
  • Prisoner
  • Abnormal contralateral forearm
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Jesse B. Jupiter, MD, Massachusetts General Hospital
Massachusetts General Hospital
AO foundation
Principal Investigator: Jupiter Jesse, MD MGH
Massachusetts General Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP