Extra-articular Distal Radius MalunionsPhase 2NCT01897246
Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion
A Phase 2 study testing Corrective osteotomy with computer-assisted pre-operative planning and Corrective osteotomy with conventional preoperative planning in people with Extra-articular Distal Radius Malunions, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extra-articular Distal Radius Malunions
- What is being tested?
- Corrective osteotomy with computer-assisted pre-operative planning and Corrective osteotomy with conventional preoperative planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (over 18 yrs of age)
- Extra-articular malunion of the distal radius
- Fluent in English
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Christine M. Kleinert Institute of Hand and Microsurgery
Louisville, Kentucky, 40202
About this study
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.
- Conditions
- Extra-articular Distal Radius Malunions
- Being tested
- Corrective osteotomy with computer-assisted pre-operative planning, Corrective osteotomy with conventional preoperative planning
- Keywords
- distal radius malunion, extra-articular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrective osteotomy with computer-assisted pre-operative planningProcedure or surgery
The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.
Corrective osteotomy with conventional preoperative planningProcedure or surgery
The corrective osteotomy will be planned with conventional preoperative planning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Corrective osteotomy with conventional preoperative planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip strength as compared to the normal, contralateral hand is considered the most important outcome measure for patients with distal radius fractures.
Measured: Up to 12 months
Secondary outcomes (4)
Range of motion
Measured: Up to 12 months
DASH Questionnaire
Measured: Up to 12 months
Mayo Wrist score
Measured: Up to 12 months
Gartland and Werley score
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extra-articular Distal Radius MalunionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Collaborators
- AO Research Fund
- Responsible party
- Sponsor
- Investigators
- Rodrgio Moreno, MD, Principal investigator, Christine M. Kleinert Institute of Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897246
- Sponsor's protocol ID
- 10.0363
- Status last verified
- Jul 2013
- First submitted
- 11 Jun 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion
- ClinicalTrials.gov ID
- NCT01897246
- Acronym / sponsor ID
- 10.0363
- Conditions
- Extra-articular Distal Radius Malunions
- Keywords
- distal radius malunion, extra-articular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Collaborators
- AO Research Fund
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted pre-operative planning | Active comparator | Procedure: Corrective osteotomy with computer-assisted pre-operative planningPatients enrolled in this arm will undergo corrective surgery of the distal radius, with pre-operative computer-assisted planning and virtual osteotomy. |
| Conventional pre-operative planning | Active comparator | Procedure: Corrective osteotomy with conventional preoperative planningPatients in this group will undergo corrective osteotomy of the distal radius wit conventional pre-operative planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (over 18 yrs of age)
- Extra-articular malunion of the distal radius
- Fluent in English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrective osteotomy with computer-assisted pre-operative planningThe corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy. | Procedure or surgery | Computer-assisted pre-operative planning |
| Corrective osteotomy with conventional preoperative planningThe corrective osteotomy will be planned with conventional preoperative planning. | Procedure or surgery | Conventional pre-operative planning |
Primary outcome
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.
4 secondary outcomes
Range of motion
Time frame: Up to 12 months
DASH Questionnaire
Time frame: Up to 12 months
Mayo Wrist score
Time frame: Up to 12 months
Gartland and Werley score
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Distal Femoral Fractures, Extra-articular Distal Radius Malunions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrgio Moreno, MD principal investigator
Christine M. Kleinert Institute of Hand and Microsurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Corrective osteotomy with computer-assisted pre-operative planning and Corrective osteotomy with conventional preoperative planning in people with Extra-articular Distal Radius Malunions, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.