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Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

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ClinicalTrials.gov Identifier: NCT01193010
Recruitment Status : Unknown
Verified October 2016 by Jesse B. Jupiter, MD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2010
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
AO foundation
Information provided by (Responsible Party):
Jesse B. Jupiter, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Extraarticular Distal Radius Malunion Procedure: Computer-Assisted Surgical Planning Procedure: distal radius osteotomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
Study Start Date : August 2010
Estimated Primary Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Control
Surgery without computer-assisted 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.

Experimental: Computer-Assisted Surgical Planning 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.




Primary Outcome Measures :
  1. grip strength [ Time Frame: 3, 6, 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant patient
  • Prisoner
  • Abnormal contralateral forearm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193010


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
AO foundation
Investigators
Principal Investigator: Jupiter Jesse, MD MGH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesse B. Jupiter, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01193010     History of Changes
Other Study ID Numbers: 2010P000444
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016