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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
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

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : May 2010
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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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
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
AO foundation
Investigators
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Principal Investigator: Jupiter Jesse, MD MGH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jesse B. Jupiter, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01193010    
Other Study ID Numbers: 2010P000444
First Posted: September 1, 2010    Key Record Dates
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019
Last Verified: March 2019