Closed Fracture of Lower End of Radius and UlnaNCT02312128
Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
A study testing Questionnaire, X- Ray and Grip Strength in people with Closed Fracture of Lower End of Radius and Ulna, run by Ludwig Boltzmann Gesellschaft at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Closed Fracture of Lower End of Radius and Ulna
- What is being tested?
- Questionnaire, X- Ray and Grip Strength
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Jul 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years
- A2 - C3 distal radius fracture
- no acute or older injury that influences hand function
- operative stabilized by palmar angle stable plate
Who cannot join
- Age ≥ 76 years
- Age < 18 years
- C3.3 radius fracture
- acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
Trial locations and contacts
1 site in 1 country.
Austria1 site
Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler
Vienna, 1200
About this study
The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast
Read the detailed description
All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.
The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.
In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.
- Inclusion criteria:
- Age ≥ 18 and ≤ 75 years
- A2 - C3 distal radius fracture
- no acute or older injury that influences hand function
- operative stabilized by palmar angle stable plate
- Exclusion criteria:
- Age ≥ 76 years
- Age < 18 years
- C3.3 radius fracture
- acute or preexisting injures that influences hand function
- pregnancy
- neurologic disorders
- incapacitated people
- Being tested
- Questionnaire, X- Ray, Grip Strength, VAS Score, Range of Motion measurement
- Keywords
- distal radius fractures, early mobilization, postoperative treatment, outcome
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
DASH Score, PRWE Score, Mayo Wrist Score
X- RayRadiation
X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery
Grip StrengthOther
Grip strength measurement
VAS ScoreOther
Measurement pain according to the visual analogue scale (VAS)
Range of Motion measurementOther
Angle measurement of the active range of motion in the wrist
| Study group | Role | What they receive |
|---|---|---|
| Early Mobilisation | Active comparator | receives a removable plastic cast for one week and is allowed to move the wrist directly postoperative.
Interventions:
* Range of Motion measurement (ROM),
* Grip strength measurement,
* VAS Score according to the visual analogue scale ().
* Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score.
* X- Rays in two planes.
Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery Receives: Other: Questionnaire; Radiation: X- Ray; Other: Grip Strength; Other: VAS Score; Other: Range of Motion measurement |
| Cast Group | Active comparator | receives a non removable cast for 5 weeks
Interventions:
* Range of Motion measurement (ROM),
* Grip strength measurement,
* VAS Score according to the visual analogue scale ().
* Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score.
* X- Rays in two planes.
Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery Receives: Other: Questionnaire; Radiation: X- Ray; Other: Grip Strength; Other: VAS Score; Other: Range of Motion measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome as measured by visual analogue scale (VAS)
Pain evaluation according the VAS Score
Measured: one year
Functional Outcome as measured by Range of Motion (ROM)
Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Measured: one year
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score
Questionnaire: PRWE Score
Measured: one year
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
Questionnaire: DASH Score
Measured: One Year
Functional Outcome as measured by Mayo Wrist Score
Questionnaire: Mayo Wrist Score
Measured: One year
Radiological outcome as measured by X-Ray
Radiological outcome in x-ray of the Wrist in two planes
Measured: One Year
Functional Outcome as measured by Grip Strength
Measured: one year
Secondary outcomes (7)
change Range of motion
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Pain
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Patient-Rated Wrist Evaluation (PRWE) Score
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Mayo Wrist Score
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray
X-Ray of the wrist in two planes
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Grip strength
Measured: 6., 9., 12. week postsurgery, a half and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of Lower End of Radius and UlnaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Gesellschaft
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Responsible party
- Principal investigator, Stefan Quadlbauer, M.D., AUVA Traumazentrum Vienna Site UKH Meidling
- Investigators
- Stefan Quadlbauer, M.D., Principal investigator, AUVA Traumazentrum Vienna Site UKH MeidlingMartin Leixnering, M.D., Study director, AUVA Traumazentrum Vienna Site UKH Meidling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312128
- Sponsor's protocol ID
- 03/2010
- Status last verified
- Feb 2019
- First submitted
- 1 Dec 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT02312128
- Acronym / sponsor ID
- 03/2010
- Keywords
- distal radius fractures, early mobilization, postoperative treatment, outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ludwig Boltzmann GesellschaftUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Dec 2014 (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 evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast
Detailed description
All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.
The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.
In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.
- Inclusion criteria:
- Age ≥ 18 and ≤ 75 years
- A2 - C3 distal radius fracture
- no acute or older injury that influences hand function
- operative stabilized by palmar angle stable plate
- Exclusion criteria:
- Age ≥ 76 years
- Age < 18 years
- C3.3 radius fracture
- acute or preexisting injures that influences hand function
- pregnancy
- neurologic disorders
- incapacitated people
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Mobilisation | Active comparator | Other: Questionnaire, Radiation: X- Ray, Other: Grip Strength, Other: VAS Score, Other: Range of Motion measurementreceives a removable plastic cast for one week and is allowed to move the wrist directly postoperative. Interventions: * Range of Motion measurement (ROM), * Grip strength measurement, * VAS Score according to the visual analogue scale (). * Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. * X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery |
| Cast Group | Active comparator | Other: Questionnaire, Radiation: X- Ray, Other: Grip Strength, Other: VAS Score, Other: Range of Motion measurementreceives a non removable cast for 5 weeks Interventions: * Range of Motion measurement (ROM), * Grip strength measurement, * VAS Score according to the visual analogue scale (). * Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. * X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 75 years
- A2 - C3 distal radius fracture
- no acute or older injury that influences hand function
- operative stabilized by palmar angle stable plate
Key exclusion criteria (4 listed)
- Age ≥ 76 years
- Age < 18 years
- C3.3 radius fracture
- acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people
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 |
|---|---|---|
| QuestionnaireDASH Score, PRWE Score, Mayo Wrist Score | Other | Cast Group, Early Mobilisation |
| X- RayX-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery | Radiation | Cast Group, Early Mobilisation |
| Grip StrengthGrip strength measurement | Other | Cast Group, Early Mobilisation |
| VAS ScoreMeasurement pain according to the visual analogue scale (VAS) | Other | Cast Group, Early Mobilisation |
| Range of Motion measurementAngle measurement of the active range of motion in the wrist | Other | Cast Group, Early Mobilisation |
Primary outcome
Functional Outcome as measured by visual analogue scale (VAS)
Time frame: one year
Pain evaluation according the VAS Score
Functional Outcome as measured by Range of Motion (ROM)
Time frame: one year
Range of Motion measured in sagittal plane, frontal plane and forearm rotation
Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score
Time frame: one year
Questionnaire: PRWE Score
Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: One Year
Questionnaire: DASH Score
Functional Outcome as measured by Mayo Wrist Score
Time frame: One year
Questionnaire: Mayo Wrist Score
Radiological outcome as measured by X-Ray
Time frame: One Year
Radiological outcome in x-ray of the Wrist in two planes
Functional Outcome as measured by Grip Strength
Time frame: one year
7 secondary outcomes
change Range of motion
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Pain
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Patient-Rated Wrist Evaluation (PRWE) Score
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change Mayo Wrist Score
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Change X-Ray
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
Grip strength
Time frame: 6., 9., 12. week postsurgery, a half and one year after surgery
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 4 Feb 2019.
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.
Stefan Quadlbauer, M.D. principal investigator
AUVA Traumazentrum Vienna Site UKH Meidling
Martin Leixnering, M.D. study director
AUVA Traumazentrum Vienna Site UKH Meidling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire, X- Ray and Grip Strength in people with Closed Fracture of Lower End of Radius and Ulna, run by Ludwig Boltzmann Gesellschaft at 1 site in Austria.
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 4 inclusion and 4 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 4 Feb 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 Austria. 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?
Functional Outcome as measured by visual analogue scale (VAS) (time frame: one year). The study lists 7 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 4 Feb 2019.