Distal Radius FractureNCT01778673
Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study
An observational study of Distal Radius Fracture and Radiological Outcome, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Background: Although fractures of the distal radius are the most common skeletal injury, the utility of the available classification systems to predict fracture stability is limited. We studied if cortical comminution and intra-articular involvement can assess instability in fractures of the distal radius. Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Distal Radius Fracture, Radiological Outcome
- What is being tested?
- Cast immobilization
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Sep 2011
- Phase
- Observational
- 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 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.
Who cannot join
- Dementia, previous fracture to the ipsilateral wrist, open fracture, other concomitant or existing damage or injury to the wrist, Galeazzi fracture, rheumatoid arthritis, alcohol or drug abuse and neurologic impairment.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of orthopedic surgery Sundsvall Hospital
Sundsvall, Sundsvall, 851 86
About this study
Background: Although fractures of the distal radius are the most common skeletal injury, the utility of the available classification systems to predict fracture stability is limited. We studied if cortical comminution and intra-articular involvement can assess instability in fractures of the distal radius.
Methods: A prospective multicenter study was conducted. Distal radius fractures in 417 skeletally mature patients (428 fractures) were studied. Fractures were divided into osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and lateral plain radiographs determined if the fractures were minimally displaced or displaced. The fracture patterns were evaluated depending on the presence and the site of cortical comminution and intra-articular involvement according to a new classification system (Buttazzoni classification). Minimally displaced fractures were treated with cast immobilization. Displaced fractures underwent closed reduction with subsequent cast immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months. Displacement was classified as primary instability, secondary instability or late instability. Endpoints were union of the fracture or re-displacement. Results: Volarly comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni 3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni 1) in 16 % of the cases. One third of the initially minimally displaced fractures did not maintain acceptable alignment. All initially displaced volarly comminuted fractures were unstable. In both initially displaced and minimally displaced fractures, cortical comminution and intra-articular involvement were predictive for primary, secondary and late instability.
Conclusions: Cortical comminution and intra-articular involvement seem to be valuable instruments for assessing stability at initial presentation of distal radius fractures. Level of Evidence: Level I, prospective multicenter study. Prognostic study.
Read the detailed description
Between the 1st of October 2009 and the 30th of September 2011 patients with DRF at two teaching hospitals were invited to participate in a prospective study. Patients between 15 and 74 years, with closed physes of the distal radius and ulna were included. Exclusion criteria were dementia, previous fracture to the ipsilateral wrist, open fracture, other concomitant or existing damage or injury to the wrist, Galeazzi fracture, rheumatoid arthritis, alcohol or drug abuse and neurologic impairment. All patients underwent radiographic examination with frontal and lateral views centered on the wrist in neutral rotation. The radiographs were classified by the doctor on-call who had the needed information about the classification system available.
Undisplaced or minimally displaced fractures (will be called minimally displaced throughout this article) were immobilized in a Plaster-of-Paris (PoP) slab from distal to the elbow to proximal to the MCP-joints with the wrist in a neutral position. Displaced fractures were reduced under hematoma-block local anesthesia, immobilized with PoP slab and then radiologically re-examined. In cases of re-displacement at post-reduction x-ray, the fractures were registered as primary instability and further treated according to the guidelines of the treating department. Both if the fracture was minimally displaced and if reduction was successful radiographic examination was performed after 10-14 days.
If still acceptable at 10-14 days, the fractures were treated in PoP slab for totally 4-6 weeks. If the fracture at follow up had displaced, it was registered as secondary instability and further treatment was discussed. After 3 or more months radiographs were again obtained to confirm union and final position of the fracture. Fractures with an acceptable position at 10-14 days which later mal-united were registered as late instability.
If reduction to an acceptable position was not achieved initially or was lost at the 10-14 days control this was considered to be the end-point for this particular fracture in this study. Thus all fractures that entered and finished this study can either be considered to have been stable i.e. went to union in an acceptable position without operation, or were fractures that at one point or another showed that they were so unstable that an acceptable position could not be established or kept with conservative means.
Acceptable position To define acceptable and non-acceptable positions we used specific radiographic criteria. We measured volar inclination, radial tilt, ulnar variance and any eventual intra-articular step-off. It is considered that elderly people tolerate more displacement than younger people (6,10). Some authors have made an arbitrary definition, considering females above 49 years and males above 59 years as osteoporotic. Therefore; we have divided the patients into two groups, one "younger" below and one "elderly" above these ages.
For the "elderly" we accepted volar inclination up to 20°, dorsal tilt up to 10° and radial tilt of 10° or more. For the "younger" we accepted volar inclination up to 15°, dorsal tilt up to 10° and radial tilt of 15° or more. Up to 2 mm. of ulnar variance and less than 2 mm. of intra-articular step-off were acceptable in both groups.
Statistics The Fischer's exact test was used to compare each pair of class. To correct for multiple comparisons the p-values from the Fischer's exact test was corrected with Benjamini Hochberg correction. IBM SPSS 20 was used for most analysis, except for the Fischer exact with the correction where R, version 2.15 (http://www.r-project.org), was used with package fmsb. A p-value <0.05 is considered statistically significant. The false-discovery-rate for the Benjamini-Hochberg correction was set as 0.05.
- Conditions
- Distal Radius Fracture, Radiological Outcome
- Being tested
- Cast immobilization
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast immobilizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Distal radius fractures Sundsvall Hospital | Not described Receives: Procedure: Cast immobilization | |
| Distal radius fractures Östersund Hospital. | Not described Receives: Procedure: Cast immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture displacement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startOct 2009
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778673
- Sponsor's protocol ID
- 09-213
- Status last verified
- Jan 2013
- First submitted
- 24 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01778673
- Acronym / sponsor ID
- 09-213
- Conditions
- Distal Radius Fracture, Radiological Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- First posted
- 29 Jan 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.
Background: Although fractures of the distal radius are the most common skeletal injury, the utility of the available classification systems to predict fracture stability is limited. We studied if cortical comminution and intra-articular involvement can assess instability in fractures of the distal radius.
Methods: A prospective multicenter study was conducted. Distal radius fractures in 417 skeletally mature patients (428 fractures) were studied. Fractures were divided into osteoporotic or non-osteoporotic according to age of the patients. Antero-posterior and lateral plain radiographs determined if the fractures were minimally displaced or displaced. The fracture patterns were evaluated depending on the presence and the site of cortical comminution and intra-articular involvement according to a new classification system (Buttazzoni classification). Minimally displaced fractures were treated with cast immobilization. Displaced fractures underwent closed reduction with subsequent cast immobilization. Radiographs were obtained after reduction, at 10-14 days and after 3 months. Displacement was classified as primary instability, secondary instability or late instability. Endpoints were union of the fracture or re-displacement. Results: Volarly comminuted fractures (Buttazzoni 4) displaced in 96 %, intra-articular fractures (Buttazzoni 3) in 72%, dorsally comminuted fractures (Buttazzoni 2) in 73% and non-comminuted (Buttazzoni 1) in 16 % of the cases. One third of the initially minimally displaced fractures did not maintain acceptable alignment. All initially displaced volarly comminuted fractures were unstable. In both initially displaced and minimally displaced fractures, cortical comminution and intra-articular involvement were predictive for primary, secondary and late instability.
Conclusions: Cortical comminution and intra-articular involvement seem to be valuable instruments for assessing stability at initial presentation of distal radius fractures. Level of Evidence: Level I, prospective multicenter study. Prognostic study.
Detailed description
Between the 1st of October 2009 and the 30th of September 2011 patients with DRF at two teaching hospitals were invited to participate in a prospective study. Patients between 15 and 74 years, with closed physes of the distal radius and ulna were included. Exclusion criteria were dementia, previous fracture to the ipsilateral wrist, open fracture, other concomitant or existing damage or injury to the wrist, Galeazzi fracture, rheumatoid arthritis, alcohol or drug abuse and neurologic impairment. All patients underwent radiographic examination with frontal and lateral views centered on the wrist in neutral rotation. The radiographs were classified by the doctor on-call who had the needed information about the classification system available.
Undisplaced or minimally displaced fractures (will be called minimally displaced throughout this article) were immobilized in a Plaster-of-Paris (PoP) slab from distal to the elbow to proximal to the MCP-joints with the wrist in a neutral position. Displaced fractures were reduced under hematoma-block local anesthesia, immobilized with PoP slab and then radiologically re-examined. In cases of re-displacement at post-reduction x-ray, the fractures were registered as primary instability and further treated according to the guidelines of the treating department. Both if the fracture was minimally displaced and if reduction was successful radiographic examination was performed after 10-14 days.
If still acceptable at 10-14 days, the fractures were treated in PoP slab for totally 4-6 weeks. If the fracture at follow up had displaced, it was registered as secondary instability and further treatment was discussed. After 3 or more months radiographs were again obtained to confirm union and final position of the fracture. Fractures with an acceptable position at 10-14 days which later mal-united were registered as late instability.
If reduction to an acceptable position was not achieved initially or was lost at the 10-14 days control this was considered to be the end-point for this particular fracture in this study. Thus all fractures that entered and finished this study can either be considered to have been stable i.e. went to union in an acceptable position without operation, or were fractures that at one point or another showed that they were so unstable that an acceptable position could not be established or kept with conservative means.
Acceptable position To define acceptable and non-acceptable positions we used specific radiographic criteria. We measured volar inclination, radial tilt, ulnar variance and any eventual intra-articular step-off. It is considered that elderly people tolerate more displacement than younger people (6,10). Some authors have made an arbitrary definition, considering females above 49 years and males above 59 years as osteoporotic. Therefore; we have divided the patients into two groups, one "younger" below and one "elderly" above these ages.
For the "elderly" we accepted volar inclination up to 20°, dorsal tilt up to 10° and radial tilt of 10° or more. For the "younger" we accepted volar inclination up to 15°, dorsal tilt up to 10° and radial tilt of 15° or more. Up to 2 mm. of ulnar variance and less than 2 mm. of intra-articular step-off were acceptable in both groups.
Statistics The Fischer's exact test was used to compare each pair of class. To correct for multiple comparisons the p-values from the Fischer's exact test was corrected with Benjamini Hochberg correction. IBM SPSS 20 was used for most analysis, except for the Fischer exact with the correction where R, version 2.15 (http://www.r-project.org), was used with package fmsb. A p-value <0.05 is considered statistically significant. The false-discovery-rate for the Benjamini-Hochberg correction was set as 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal radius fractures Sundsvall Hospital | – | Procedure: Cast immobilization |
| Distal radius fractures Östersund Hospital. | – | Procedure: Cast immobilization |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.
Key exclusion criteria (1 listed)
- Dementia, previous fracture to the ipsilateral wrist, open fracture, other concomitant or existing damage or injury to the wrist, Galeazzi fracture, rheumatoid arthritis, alcohol or drug abuse and neurologic impairment.
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 |
|---|---|---|
| Cast immobilization | Procedure or surgery | Distal radius fractures Sundsvall Hospital, Distal radius fractures Östersund Hospital. |
Primary outcome
Fracture displacement
Time frame: 3 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 29 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture and Radiological Outcome, run by Sundsvall Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 29 Jan 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 Sweden. 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?
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?
Fracture displacement (time frame: 3 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 29 Jan 2013.