Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014