Distal Radius FractureNCT00609479
Comparison of Two Methods for Treatment of Colles´s Fracture
A study testing Osteosynthesis in people with Distal Radius Fracture and Colle´s Fracture, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Colle´s Fracture
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesDenmark
- Study dates
- Jan 2008to Feb 2010
- Phase
- Interventional
- 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
- Fracture Older type 2.
- Fracture Older type 3.
Who cannot join
- Fractures older than 3 weeks.
- Pregnancy.
- Seq. after previous fracture.
- Distal fragments volar cortex < 10 mm.
- Open fracture larger than Gustillo 1.
- Disability due to other illness.
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- Congenital abnormity or injury/disease in the affected extremity.
- Not capable of mentally/physically to cooperate.
- Not able to go to followup on the operating hospital.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Regionhospital Herning
Herning, 7400
Regionhospital Holstebro
Holstebro, 7500
Regionhospital Viborg
Viborg, 8800
About this study
Official title: Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.
- Conditions
- Distal Radius Fracture, Colle´s Fracture
- Being tested
- Osteosynthesis
- Keywords
- Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
- Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12.
- Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Internal fixation with Micronail. 41 patients. Receives: Procedure: Osteosynthesis |
| 2 | Experimental | External fixation with Hoffmann-II-non-bridging. 41 patients. Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH-questionnaire
Measured: 3 months
Secondary outcomes (1)
PRWE-questionnaire
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 posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- More trials run by University of AarhusThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Kjeld Søballe, MD; PhD; Prof., Study chair, Department of Orthopedics, University of Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609479
- Sponsor's protocol ID
- JOS-1
- Other IDs
- JOS-1
- Status last verified
- Apr 2010
- First submitted
- 24 Jan 2008
- Last updated
- 12 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
- ClinicalTrials.gov ID
- NCT00609479
- Acronym / sponsor ID
- JOS-1
- Conditions
- Distal Radius Fracture, Colle´s Fracture
- Keywords
- Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Feb 2008 (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 purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: OsteosynthesisInternal fixation with Micronail. 41 patients. |
| 2 | Experimental | Procedure: OsteosynthesisExternal fixation with Hoffmann-II-non-bridging. 41 patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fracture Older type 2.
- Fracture Older type 3.
Key exclusion criteria (9 listed)
- Fractures older than 3 weeks.
- Pregnancy.
- Seq. after previous fracture.
- Distal fragments volar cortex < 10 mm.
- Open fracture larger than Gustillo 1.
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 |
|---|---|---|
| Osteosynthesis1. Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. 2. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12. | Procedure or surgery | 1, 2 |
Primary outcome
DASH-questionnaire
Time frame: 3 months
1 secondary outcome
PRWE-questionnaire
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 12 Apr 2010.
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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.
Kjeld Søballe, MD; PhD; Prof. study chair
Department of Orthopedics, University of Aarhus, Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis in people with Distal Radius Fracture and Colle´s Fracture, run by University of Aarhus at 3 sites in Denmark.
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 2 inclusion and 9 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 12 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
DASH-questionnaire (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 12 Apr 2010.