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Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AO foundation
Information provided by (Responsible Party):
Jesse B. Jupiter, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01193010
First received: August 30, 2010
Last updated: October 30, 2014
Last verified: October 2014

August 30, 2010
October 30, 2014
August 2010
December 2015   (final data collection date for primary outcome measure)
grip strength [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01193010 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
Not Provided
December 2015   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01193010
2010P000444
No
Jesse B. Jupiter, MD, Massachusetts General Hospital
Massachusetts General Hospital
AO foundation
Principal Investigator: Jupiter Jesse, MD MGH
Massachusetts General Hospital
October 2014

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