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OpenTrials
Completed

NCT Number: NCT01897246

Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

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.

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Key information

Conditions

Extra-articular Distal Radius Malunions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corrective osteotomy with computer-assisted pre-operative planning

Procedure

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

Corrective osteotomy with conventional preoperative planning

Procedure

The corrective osteotomy will be planned with conventional preoperative planning.

Primary outcomes

  1. 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

  1. Range of motion

    Time frame: Up to 12 months

  2. DASH Questionnaire

    Time frame: Up to 12 months

  3. Mayo Wrist score

    Time frame: Up to 12 months

  4. Gartland and Werley score

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Other

Collaborators

  • AO Research Fund

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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