Radius Fracture DistalNCT03186963
Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures
A study testing No immobilization and Volar splint in people with Radius Fracture Distal, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- No immobilization and Volar splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intra-articular distal radius fracture treated with volar locking plate fixation;
- Fracture occurred within the prior 30 days;
- Consent to participate in the study
Who cannot join
- Concomitant fracture of the ipsilateral upper limb
- Previous lesion of the ipsilateral upper limb with functional deficit
- Bilateral fracture
- Concomitant neurologic injury
- Patient not amenable to follow-up
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Orthopedics and Traumatology - University of Sao Paulo
São Paulo, São Paulo, 05403010
About this study
Official title: Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.
Read the detailed description
Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.
- Conditions
- Radius Fracture Distal
- Being tested
- No immobilization, Volar splint
- Keywords
- distal radius fracture, volar plate, 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.
No immobilizationProcedure or surgery
Conventional wrist dressing
Volar splintProcedure or surgery
Volar plaster splint
| Study group | Role | What they receive |
|---|---|---|
| No immobilization | Experimental | Patients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively. Receives: Procedure: No immobilization |
| Volar splint | Active comparator | Patients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy. Receives: Procedure: Volar splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain
Visual analogue scale for pain
Measured: 12 hours
Level of pain
Visual analogue scale for pain
Measured: 18 hours
Level of pain
Visual analogue scale for pain
Measured: 24 hours
Level of pain
Visual analogue scale for pain
Measured: Once a day in the first week
Level of pain
Visual analogue scale for pain
Measured: 2 weeks
Secondary outcomes (16)
Level of pain
Visual analogue scale for pain
Measured: 6 weeks
Level of pain
Visual analogue scale for pain
Measured: 3 months
Level of pain
Visual analogue scale for pain
Measured: 6 months
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 6 weeks
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 3 months
DASH score
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 6 months
Wrist flexion-extension arc
Assessed by goniometry
Measured: 2 weeks
Wrist flexion-extension arc
Assessed by goniometry
Measured: 6 weeks
Wrist flexion-extension arc
Assessed by goniometry
Measured: 3 months
Wrist flexion-extension arc
Assessed by goniometry
Measured: 6 months
Forearm rotation arc
Assessed by goniometry
Measured: 2 weeks
Forearm rotation arc
Assessed by goniometry
Measured: 6 weeks
Forearm rotation arc
Assessed by goniometry
Measured: 3 months
Forearm rotation arc
Assessed by goniometry
Measured: 6 months
Tramadol use
Percentage of patients requesting additional analgesia with tramadol in the first week
Measured: Once a day in the first week post-op
Complication
Percentage of patients presenting with any type of local orthopedic complication
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startMay 2013
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando B Andrade-Silva, MD, University of Sao Paulo
- Investigators
- Kodi E Kojima, MD, Study chair, Institute of Orthopedics - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186963
- Sponsor's protocol ID
- Distalradius
- Status last verified
- Mar 2018
- First submitted
- 19 Jan 2017
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03186963
- Acronym / sponsor ID
- Distalradius
- Conditions
- Radius Fracture Distal
- Keywords
- distal radius fracture, volar plate, immobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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 determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.
Detailed description
Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No immobilization | Experimental | Procedure: No immobilizationPatients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively. |
| Volar splint | Active comparator | Procedure: Volar splintPatients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intra-articular distal radius fracture treated with volar locking plate fixation;
- Fracture occurred within the prior 30 days;
- Consent to participate in the study
Key exclusion criteria (5 listed)
- Concomitant fracture of the ipsilateral upper limb
- Previous lesion of the ipsilateral upper limb with functional deficit
- Bilateral fracture
- Concomitant neurologic injury
- Patient not amenable to follow-up
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 |
|---|---|---|
| No immobilizationConventional wrist dressing | Procedure or surgery | No immobilization |
| Volar splintVolar plaster splint | Procedure or surgery | Volar splint |
Primary outcome
Level of pain
Time frame: 12 hours
Visual analogue scale for pain
Level of pain
Time frame: 18 hours
Visual analogue scale for pain
Level of pain
Time frame: 24 hours
Visual analogue scale for pain
Level of pain
Time frame: Once a day in the first week
Visual analogue scale for pain
Level of pain
Time frame: 2 weeks
Visual analogue scale for pain
16 secondary outcomes
Level of pain
Time frame: 6 weeks
Level of pain
Time frame: 3 months
Level of pain
Time frame: 6 months
DASH score
Time frame: 6 weeks
DASH score
Time frame: 3 months
DASH score
Time frame: 6 months
Wrist flexion-extension arc
Time frame: 2 weeks
Wrist flexion-extension arc
Time frame: 6 weeks
Wrist flexion-extension arc
Time frame: 3 months
Wrist flexion-extension arc
Time frame: 6 months
Forearm rotation arc
Time frame: 2 weeks
Forearm rotation arc
Time frame: 6 weeks
Forearm rotation arc
Time frame: 3 months
Forearm rotation arc
Time frame: 6 months
Tramadol use
Time frame: Once a day in the first week post-op
Complication
Time frame: up to 24 weeks
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 16 Mar 2018.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Kodi E Kojima, MD study chair
Institute of Orthopedics - University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No immobilization and Volar splint in people with Radius Fracture Distal, run by University of Sao Paulo at 1 site in Brazil.
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 5 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 16 Mar 2018. 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 Brazil. 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?
Level of pain (time frame: 12 hours). The study lists 5 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 16 Mar 2018.