Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase: Completed; Phase 2

Conditions: Extra-articular Distal Radius Malunions

Treatments: Procedure: Corrective osteotomy with computer-assisted pre-operative planning; Procedure: Corrective osteotomy with conventional preoperative planning

Study type: Interventional

Funder types: Other

Identifiers

NCT01897246

10.0363

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Computer-assisted pre-operative planning

Active Comparator group

Description:

Patients enrolled in this arm will undergo corrective surgery of the distal radius, with pre-operative computer-assisted planning and virtual osteotomy.

Treatment:

Procedure: Corrective osteotomy with computer-assisted pre-operative planning

Conventional pre-operative planning

Active Comparator group

Description:

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

Treatment:

Procedure: Corrective osteotomy with conventional preoperative planning