Extraarticular Distal Radius MalunionNCT01193010
Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
A study testing Computer-Assisted Surgical Planning and distal radius osteotomy in people with Extraarticular Distal Radius Malunion, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extraarticular Distal Radius Malunion
- What is being tested?
- Computer-Assisted Surgical Planning and distal radius osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Extraarticular distal radius malunion requiring surgery
- Adult patient (> 18 yo)
- Fluent in English
Who cannot join
- Pregnant patient
- Prisoner
- Abnormal contralateral forearm
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
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.
- Conditions
- Extraarticular Distal Radius Malunion
- Being tested
- Computer-Assisted Surgical Planning, distal radius osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Surgical PlanningProcedure or surgery
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 osteotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Surgery without computer-assisted planning. Receives: Procedure: distal radius osteotomy |
| Computer-Assisted Surgical Planning | Experimental | Not described Receives: Procedure: Computer-Assisted Surgical Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the Shoulder and Hand Score
DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
Measured: 0, 3, 6, 12 months
Secondary outcomes (3)
Patient-Rated Wrist Evaluation (PWRE_
PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.
Measured: 0, 3, 6, 12 months
Numerical Rating Scale for Pain
Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
Measured: 0, 3, 6, 12 months
Numerical Rating Scale for Satisfaction
Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied
Measured: 0, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extraarticular Distal Radius MalunionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AO foundation
- Responsible party
- Principal investigator, Jesse B. Jupiter, MD, Massachusetts General Hospital
- Investigators
- Jupiter Jesse, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193010
- Sponsor's protocol ID
- 2010P000444
- Status last verified
- Mar 2019
- First submitted
- 30 Aug 2010
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leong NL, Buijze GA, Fu EC, Stockmans F, Jupiter JB; Distal Radius Malunion (DiRaM) collaborative group. Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282.
PubMed 21156074
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01193010
- Acronym / sponsor ID
- 2010P000444
- Conditions
- Extraarticular Distal Radius Malunion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AO foundation
- Study start
- May 2010 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: distal radius osteotomySurgery without computer-assisted planning. |
| Computer-Assisted Surgical Planning | Experimental | Procedure: Computer-Assisted Surgical 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)
- Extraarticular distal radius malunion requiring surgery
- Adult patient (> 18 yo)
- Fluent in English
Key exclusion criteria (3 listed)
- Pregnant patient
- Prisoner
- Abnormal contralateral forearm
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 |
|---|---|---|
| Computer-Assisted Surgical PlanningUsing 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. | Procedure or surgery | Computer-Assisted Surgical Planning |
| distal radius osteotomyIn 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. | Procedure or surgery | Control |
Primary outcome
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.
3 secondary outcomes
Patient-Rated Wrist Evaluation (PWRE_
Time frame: 0, 3, 6, 12 months
Numerical Rating Scale for Pain
Time frame: 0, 3, 6, 12 months
Numerical Rating Scale for Satisfaction
Time frame: 0, 3, 6, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21156074Leong NL, Buijze GA, Fu EC, Stockmans F, Jupiter JB; Distal Radius Malunion (DiRaM) collaborative group. Computer-assisted versus non-computer-assisted preoperative planning of corrective osteotomy for extra-articular distal radius malunions: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Dec 14;11:282. doi: 10.1186/1471-2474-11-282.
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.
Jupiter Jesse, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Surgical Planning and distal radius osteotomy in people with Extraarticular Distal Radius Malunion, run by Massachusetts General Hospital 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 3 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 21 Jun 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disability of the Shoulder and Hand Score (time frame: 0, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01193010, which also lists 1 linked publication.
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 21 Jun 2019.