Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01193010|
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
|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)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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.
- Disability of the Shoulder and Hand Score [ Time Frame: 0, 3, 6, 12 months ]DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
- Patient-Rated Wrist Evaluation (PWRE_ [ Time Frame: 0, 3, 6, 12 months ]PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.
- Numerical Rating Scale for Pain [ Time Frame: 0, 3, 6, 12 months ]Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
- Numerical Rating Scale for Satisfaction [ Time Frame: 0, 3, 6, 12 months ]Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jupiter Jesse, MD||MGH|