Distal Radius FractureNCT02015468
The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
A study testing Early mobilization and Late mobilization in people with Distal Radius Fracture and Wrist Fracture, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating. The current study will test the following null hypothesis: There is no significant difference between patients who receive a cast for the first 2… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Distal Radius Fracture, Wrist Fracture
- What is being tested?
- Early mobilization and Late mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2012to 1 Jan 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Position prior to primary reduction:
- Dorsal tilt > 25°
- Radial shortening> 6 mm
- Radial inclination reduced by more than 15°
- Radiocarpal malalignment > 7 mm
- Dorsal /volar metaphyseal comminution
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- Volar displacement of the distal fragment(= Smith's fracture)
- Position after initial reduction:
- Dorsal tilt > 5°
- Radial shortening > 4 mm
- Radial inclination reduced by more than 10°
- Radiocarpal malalignment > 4 mm
Who cannot join
- Gustilo-Anderson type III open fractures
- Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
- Previous distal radius fracture or other disabling injury to the contralateral side
- Dementia or other psychiatric illness which affect compliance
- Congenital anomaly
- Bilateral radius fracture
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- Concurrent fractures to the upper or lower extremities or other illness which affect movement of the extremities
- Systemic joint disease such as rheumatoid arthritis
- Patients who do not speak Norwegian
- Pathological fracture other than osteoporotic fracture
- Congenital bone disease (for example osteogenesis imperfecta)
- Age below 18 and above 70
- Patients not belonging to Akershus University Hospital
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.
The current study will test the following null hypothesis:
There is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.
Read the detailed description
The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.
In a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Being tested
- Early mobilization, Late mobilization
- Keywords
- Distal radius fracture, Wrist fracture, Physiotherapy, Immobilization, Volar locking plates, Mobilization
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationOther
Early weightbearing and physiotherapy
Late mobilizationOther
Late mobilization, none-weightbearing and home exercises
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | Not described Receives: Other: Early mobilization |
| Late mobilization | Experimental | Not described Receives: Other: Late mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
The Quick-DASH score is a measure of patient reported satisfaction score and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone.
Measured: 2 years
Short Form 36 (SF36)
The SF-36 score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Secondary outcomes (6)
Patient Rated Wrist Evaluation (PRWE)
The PRWE-score is a measure of patient reported satisfaction and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Euro-Qol 5 dimension score (EQ-5d)
The EQ-5d score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Pain Scores on the Visual Analog Scale (VAS)
The VAS-score is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Radiological findings (X-ray)
Angles, incongruity and other radiological parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Range of motion (ROM)
Wrist range of motion is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 yars
Cost analysis
The cost of treatment, sick-leave, complications and other socioeconomical parameters are compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start15 Jan 2012
- Primary completion17 Jun 2016
- Study completion1 Jan 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola-Lars Hammer, University Hospital, Akershus
- Investigators
- Jan Erik Madsen, Professor, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015468
- Sponsor's protocol ID
- 2011/1393A
- Status last verified
- Aug 2020
- First submitted
- 10 Dec 2013
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating
- ClinicalTrials.gov ID
- NCT02015468
- Acronym / sponsor ID
- 2011/1393A
- Conditions
- Distal Radius Fracture, Wrist Fracture
- Keywords
- Distal radius fracture, Wrist fracture, Physiotherapy, Immobilization, Volar locking plates, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 15 Jan 2012 (actual)
- Primary completion
- 17 Jun 2016 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 19 Dec 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.
A prospective, randomized study investigating the possible benefits of immediate mobilization and frequent physiotherapy following a wrist fracture treated by volar plating.
The current study will test the following null hypothesis:
There is no significant difference between patients who receive a cast for the first 2 weeks postoperatively and then instructions in home exercises and patients who receive a cast for 2-3 days postoperatively and then have frequent sessions with a physiotherapist following volar locked plating for a extraarticular distal radius fracture, as evaluated by self-reported satisfaction after 3 months.
Detailed description
The study will focus on patients treated with volar locked plating following an extraarticular distal radius fracture.
In a prospective manner the investigators intend to analyze hand function, x-ray and other parameters in order to investigate whether early mobilization and a targeted program of physiotherapy postoperatively leads to a better functional result and earlier return to a normal activity level. The investigators analysis will also focus on the safety of early mobilization with regards to possible detrimental effects on the osteosynthesis, bony union, associated soft-tissue injuries and functional outcome. The investigators also intend to assess the cost of more intensive follow-up and physiotherapy and do a cost-benefit evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | Experimental | Other: Early mobilization |
| Late mobilization | Experimental | Other: Late mobilization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Dorsal tilt > 25°
- Radial shortening> 6 mm
- Radial inclination reduced by more than 15°
- Radiocarpal malalignment > 7 mm
- Dorsal /volar metaphyseal comminution
Key exclusion criteria (13 listed)
- Gustilo-Anderson type III open fractures
- Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
- Previous distal radius fracture or other disabling injury to the contralateral side
- Dementia or other psychiatric illness which affect compliance
- Congenital anomaly
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 |
|---|---|---|
| Early mobilizationEarly weightbearing and physiotherapy | Other | Early mobilization |
| Late mobilizationLate mobilization, none-weightbearing and home exercises | Other | Late mobilization |
Primary outcome
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH)
Time frame: 2 years
The Quick-DASH score is a measure of patient reported satisfaction score and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone.
Short Form 36 (SF36)
Time frame: 2 years
The SF-36 score is a quality of life measure and is compared between the group receiving early mobilization, weightbearing and physical therapy and the group receiving late mobilization and home exercises alone
6 secondary outcomes
Patient Rated Wrist Evaluation (PRWE)
Time frame: 2 years
Euro-Qol 5 dimension score (EQ-5d)
Time frame: 2 years
Pain Scores on the Visual Analog Scale (VAS)
Time frame: 2 years
Radiological findings (X-ray)
Time frame: 2 years
Range of motion (ROM)
Time frame: 2 yars
Cost analysis
Time frame: 2 years
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 Aug 2020.
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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.
Jan Erik Madsen, Professor study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization and Late mobilization in people with Distal Radius Fracture and Wrist Fracture, run by University Hospital, Akershus at 1 site in Norway.
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 12 inclusion and 13 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 Aug 2020. 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 Norway. 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?
Short version of "Disabilities of the Arm, Shoulder and Hand" (Quick-DASH) (time frame: 2 years). The study lists 2 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 Aug 2020.