NCT01897246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

June 11, 2012

Last Update Submit

July 9, 2013

Conditions

Extra-articular Distal Radius Malunions

Keywords

distal radius malunionextra-articular

Outcome Measures

Primary Outcomes (1)

  • Grip Strength

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

    Up to 12 months

Secondary Outcomes (4)

  • 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 Arms (2)

Computer-assisted pre-operative planning

ACTIVE COMPARATOR

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

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

Conventional pre-operative planning

ACTIVE COMPARATOR

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

Procedure: Corrective osteotomy with conventional preoperative planning

Interventions

Corrective osteotomy with computer-assisted pre-operative planningPROCEDURE

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

Computer-assisted pre-operative planning
Corrective osteotomy with conventional preoperative planningPROCEDURE

The corrective osteotomy will be planned with conventional preoperative planning.

Conventional pre-operative planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (over 18 yrs of age)
  • Extra-articular malunion of the distal radius
  • Fluent in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, 40202, United States

Location

Study Officials

  • Rodrgio Moreno, MD

    Christine M. Kleinert Institute of Hand and Microsurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

July 11, 2013

Study Start

September 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(1)