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Clinical Trials/NCT01897246
NCT01897246
Completed
Phase 2

Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Christine M. Kleinert Institute for Hand and Microsurgery1 site in 1 country10 target enrollmentSeptember 2010

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Extra-articular Distal Radius Malunions
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Enrollment
10
Locations
1
Primary Endpoint
Grip Strength
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Range of motion(Up to 12 months)
  • DASH Questionnaire(Up to 12 months)
  • Mayo Wrist score(Up to 12 months)
  • Gartland and Werley score(Up to 12 months)

Study Sites (1)

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