Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

NCT ID: NCT01897246

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Extra-articular Distal Radius Malunions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Corrective osteotomy with computer-assisted pre-operative planning

Intervention Type PROCEDURE

The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.

Conventional pre-operative planning

Patients in this group will undergo corrective osteotomy of the distal radius wit conventional pre-operative planning.

Group Type ACTIVE_COMPARATOR

Corrective osteotomy with conventional preoperative planning

Intervention Type PROCEDURE

The corrective osteotomy will be planned with conventional preoperative planning.

Interventions

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Corrective osteotomy with computer-assisted pre-operative planning

The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.

Intervention Type PROCEDURE

Corrective osteotomy with conventional preoperative planning

The corrective osteotomy will be planned with conventional preoperative planning.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Research Fund

OTHER

Sponsor Role collaborator

Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodrgio Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Christine M. Kleinert Institute of Hand and Microsurgery

Locations

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Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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10.0363

Identifier Type: -

Identifier Source: org_study_id

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