Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

This study is currently recruiting participants.
Verified December 2013 by Massachusetts General Hospital
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: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention
Extraarticular Distal Radius Malunion
Procedure: Computer-Assisted Surgical Planning
Procedure: distal radius osteotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • grip strength [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193010

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Natalie Leong       natalie_leong@hms.harvard.edu   
Principal Investigator: Jesse Jupiter, MD         
Sponsors and Collaborators
Massachusetts General Hospital
AO foundation
Investigators
Principal Investigator: Jupiter Jesse, MD MGH
  More Information

No publications provided by Massachusetts General Hospital

Additional 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
Study First Received: August 30, 2010
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 14, 2014