Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

July 9, 2013 updated by: Christine M. Kleinert Institute for Hand and Microsurgery
The investigators are comparing post-operative patient-rated functional outcome between patients who undergo corrective osteotomy for extra-articular malunited distal radius fractures with and without computer assisted pre-operative planning and virtual osteotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Christine M. Kleinert Institute of Hand and Microsurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (over 18 yrs of age)
  • Extra-articular malunion of the distal radius
  • Fluent in English

Exclusion Criteria:

  • Pregnant patients
  • prisoners
  • patients with impaired decision making ability
  • patients with a bony deformity in the distal forearm contralateral to the one with distal radius malunion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Computer-assisted pre-operative planning
Patients enrolled in this arm will undergo corrective surgery of the distal radius, with pre-operative computer-assisted planning and virtual osteotomy.
Procedure: Corrective osteotomy with computer-assisted pre-operative planning
The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.
Active Comparator: Conventional pre-operative planning
Patients in this group will undergo corrective osteotomy of the distal radius wit conventional pre-operative planning.
Procedure: Corrective osteotomy with conventional preoperative planning
The corrective osteotomy will be planned with conventional preoperative planning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Up to 12 months
Grip strength as compared to the normal, contralateral hand is considered the most important outcome measure for patients with distal radius fractures.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of motion
Time Frame: Up to 12 months
Up to 12 months
DASH Questionnaire
Time Frame: Up to 12 months
Up to 12 months
Mayo Wrist score
Time Frame: Up to 12 months
Up to 12 months
Gartland and Werley score
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Collaborators

AO Research Fund

Investigators

  • Principal Investigator: Rodrgio Moreno, MD, Christine M. Kleinert Institute of Hand and Microsurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10.0363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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