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Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01897246
Enrollment
10
Registered
2013-07-11
Start date
2010-09-30
Completion date
2013-07-31
Last updated
2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra-articular Distal Radius Malunions

Keywords

distal radius malunion, extra-articular

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.

Interventions

PROCEDURECorrective osteotomy with computer-assisted pre-operative planning

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

PROCEDURECorrective osteotomy with conventional preoperative planning

The corrective osteotomy will be planned with conventional preoperative planning.

Sponsors

AO Research Fund
CollaboratorOTHER
Christine M. Kleinert Institute for Hand and Microsurgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Grip StrengthUp to 12 monthsGrip strength as compared to the normal, contralateral hand is considered the most important outcome measure for patients with distal radius fractures.

Secondary

MeasureTime frame
Range of motionUp to 12 months
DASH QuestionnaireUp to 12 months
Mayo Wrist scoreUp to 12 months
Gartland and Werley scoreUp to 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026