Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193010
Recruitment Status : Active, not recruiting
First Posted : September 1, 2010
Last Update Posted : October 4, 2016
AO foundation
Information provided by (Responsible Party):
Jesse B. Jupiter, MD, Massachusetts General Hospital

August 30, 2010
September 1, 2010
October 4, 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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Same as current
Not Provided
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
Not Provided
Not Provided
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