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OpenTrials
Completed

NCT Number: NCT01193010

Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

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.

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Key information

Conditions

Extraarticular Distal Radius Malunion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Extraarticular distal radius malunion requiring surgery
  • Adult patient (> 18 yo)
  • Fluent in English

Exclusion criteria

  • Pregnant patient
  • Prisoner
  • Abnormal contralateral forearm

Treatment and study plan

Computer-Assisted Surgical Planning

Procedure

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.

distal radius osteotomy

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • AO foundation

Registry information

Official study title

Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2010
Registry last updated
Jun 21, 2019

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.