Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Massachusetts General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Massachusetts General Hospital
Collaborator:
AO foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01193010
First received: August 30, 2010
Last updated: June 21, 2011
Last verified: August 2010
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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 |
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):
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided by Massachusetts General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jesse Jupiter/Orthopaedic Surgeon, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01193010 History of Changes |
Other Study ID Numbers: | 2010P000444 |
Study First Received: | August 30, 2010 |
Last Updated: | June 21, 2011 |
Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on October 17, 2012