Distal Radius FractureE-MOBNCT01576224
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures
A study testing Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark in people with Distal Radius Fracture, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Feb 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 50 years of age
- Distal radius fracture suitable for volar locking plate osteosynthesis
- Inhabitants in Region Sjaelland
Who cannot join
- Dementia
- Abuse of drugs, medication or alcohol
- Open fractures
- Multitrauma or other injures on same extremity
- Earlier wrist fracture
- Delay of osteosynthesis of more than 14 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.
The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.
The primary hypothesis is, that immediate training leads to earlier and faster recovery.
Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.
Read the detailed description
Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.
- Conditions
- Distal Radius Fracture
- Being tested
- Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
- Keywords
- Volar locking plate osteosynthesis, Early mobilization, DASH
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, DenmarkDevice
To be removed during training exercises three to five times a day
| Study group | Role | What they receive |
|---|---|---|
| Immediate mobilization | Experimental | Patients start exercises immediately after osteosynthesis. Receives: Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark |
| Later mobilization | Active comparator | Patients are allowed exercises after 14 days. Receives: Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of arm, shoulder and hand score (DASH)
Measured: After 4 weeks
Disability of arm, shoulder and hand score (DASH)
Measured: After 3 months
Disability of arm, shoulder and hand score (DASH)
Measured: After 6 months
Disability of arm, shoulder and hand score (DASH)
Measured: After 12 months
Secondary outcomes (8)
Range of motion
Measured: After 4 weeks
Range of motion
Measured: After 3 months
Range of motion
Measured: After 6 months
Range of motion
Measured: After 12 months
Grip strength
Measured: After 4 weeks
Grip strength
Measured: After 3 months
Grip strength
Measured: After 6 months
Grip strength
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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 Zealand University 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Sjællands sundhedsvidenskabelige Forskningsfond
- Responsible party
- Principal investigator, Thomas Juul Sørensen, Zealand University Hospital
- Investigators
- Thomas J Sørensen, Consultant, Principal investigator, Køge Sygehus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576224
- Sponsor's protocol ID
- SJ-275
- Acronym
- E-MOB
- Status last verified
- Jan 2017
- First submitted
- 9 Apr 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01576224
- Acronym / sponsor ID
- E-MOB / SJ-275
- Conditions
- Distal Radius Fracture
- Keywords
- Volar locking plate osteosynthesis, Early mobilization, DASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Region Sjællands sundhedsvidenskabelige Forskningsfond
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Apr 2012 (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 aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.
The primary hypothesis is, that immediate training leads to earlier and faster recovery.
Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.
Detailed description
Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate mobilization | Experimental | Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, DenmarkPatients start exercises immediately after osteosynthesis. |
| Later mobilization | Active comparator | Device: Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, DenmarkPatients are allowed exercises after 14 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 50 years of age
- Distal radius fracture suitable for volar locking plate osteosynthesis
- Inhabitants in Region Sjaelland
Key exclusion criteria (6 listed)
- Dementia
- Abuse of drugs, medication or alcohol
- Open fractures
- Multitrauma or other injures on same extremity
- Earlier wrist fracture
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 |
|---|---|---|
| Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, DenmarkTo be removed during training exercises three to five times a day | Device | Immediate mobilization, Later mobilization |
Primary outcome
Disability of arm, shoulder and hand score (DASH)
Time frame: After 4 weeks
Disability of arm, shoulder and hand score (DASH)
Time frame: After 3 months
Disability of arm, shoulder and hand score (DASH)
Time frame: After 6 months
Disability of arm, shoulder and hand score (DASH)
Time frame: After 12 months
8 secondary outcomes
Range of motion
Time frame: After 4 weeks
Range of motion
Time frame: After 3 months
Range of motion
Time frame: After 6 months
Range of motion
Time frame: After 12 months
Grip strength
Time frame: After 4 weeks
Grip strength
Time frame: After 3 months
Grip strength
Time frame: After 6 months
Grip strength
Time frame: After 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 25 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Thomas J Sørensen, Consultant principal investigator
Køge Sygehus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark in people with Distal Radius Fracture, run by Zealand University Hospital at 1 site 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 3 inclusion and 6 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 25 Jan 2017. 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 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?
Disability of arm, shoulder and hand score (DASH) (time frame: After 4 weeks). The study lists 4 primary outcomes in all. 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 25 Jan 2017.