Distal Radius FracturesNCT02802774
Immobilization of Postoperative Distal Radius Fractures
A study testing Plaster Splint, Velcro Brace and Soft Dressing in people with Distal Radius Fractures, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The management of distal radius fractures has been in a state of evolution over the past 30 years. Treatment has become increasingly focused on obtaining a stable, internal construct for quick return to normal, daily activities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Plaster Splint, Velcro Brace and Soft Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to 19 Apr 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- extra and intra articular distal radius fractures treated with distal locking plates
Who cannot join
- patients with additional injuries to the ipsilateral wrist such as, distal radial ulnar joint (DRUJ) instability and associated unstable ulna fractures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sierra Pacific Orthopaedic Center
Fresno, California, 93720
Community Medical Center
Fresno, California, 93721
About this study
The management of distal radius fractures has been in a state of evolution over the past 30 years. Treatment has become increasingly focused on obtaining a stable, internal construct for quick return to normal, daily activities. With the advent of volar locking plates, the wrist fracture is stable before the patient leaves the operating room. As surgical plate and screw constructs become more stable, the need for casting and splinting may be less.
The presumptive "next step" in operative management of distal radius fractures is to do away with the postoperative splint. A review of the available English language literature failed to reveal any studies evaluating the use of postoperative splinting and patient outcomes.
This prospective, randomized study was designed to investigate the use of temporary plaster splints versus removable over-the-counter splits versus soft dressings for post-operative treatment of extra-articular and intra-articular distal radius fractures. The patients will be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.
Read the detailed description
A prospective study using multiple surgeons at multiple centers (Community Regional Medical Center and Sierra Pacific Orthopaedic Center) investigating post-operative management of extra and intra articular distal radius fractures treated with volar locking plates. Post-operative management for 2 weeks immediately following surgery will consist of placing 1/3 of patients in a short arm, custom-made, plaster splint, 1/3 with a removable Velcro wrist splint, and 1/3 with a soft dressing. The Velcro wrist brace group will be asked to wear the brace as much as possible during the two weeks and the soft dressing may be removed by the patient on the third day after surgery.
- The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place.
- The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding.
- Patients in the soft dressing group will have non-stick gauze, 4x4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab.
Patients will be randomized using REDCap Randomization module after being consented to participate in the study by the primary investigator or sub-investigator. Each investigator will have the option during and/or after surgery to remove the patient from the group they have been randomized into and treat them as they see appropriate. These patients would be documented but removed from the study follow up.
Patient satisfaction will be evaluated subjectively with the PRWE (Patient-Rated Wrist Evaluation) as well as the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Radiographs will be taken at 2, 6, 12, and 24 weeks postoperatively to measure fracture alignment and healing. Patient reported pain level, range of motion, grip, and pinch strength will be recorded at each visit as well as at a final 1 year follow-up visit. Any complication will be noted. All of these visits are part of the standard of care. The only additional part of their visit would be the brief survey including the QuickDASH and PRWE that they complete with an orthopaedic surgery resident during their visit. In addition at the first follow up appointment at 2 weeks post-surgery, patients will be asked about their satisfaction with the mobility of their wrist and those in the Velcro brace will be asked how often they wore the brace. All data will be collected on a data collection sheet and then entered into a database
- Conditions
- Distal Radius Fractures
- Being tested
- Plaster Splint, Velcro Brace, Soft Dressing
- Keywords
- Post-operative treatment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster SplintOther
The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place. Patients will wear the plaster splint for 2 weeks post-op.
Velcro BraceOther
The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding. Patients will be asked to wear the brace as much as possible for the first 2 weeks post-op.
Soft DressingOther
Patients in the soft dressing group will have non-stick gauze, 4X4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab. Patients wear the soft dressing for the first three days post-op.
| Study group | Role | What they receive |
|---|---|---|
| Plaster Splint | Active comparator | Not described Receives: Other: Plaster Splint |
| Velcro Brace | Active comparator | Not described Receives: Other: Velcro Brace |
| Soft Dressing | Active comparator | Not described Receives: Other: Soft Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation
Measured: 24 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Measured: 24 weeks
Pain Scale (on a scale from 1-10)
Measured: 24 weeks
Grip Strength measured in kilograms
Measured: 24 weeks
Pinch Strength measured in kilograms
Measured: 24 weeks
Range of Motion measured in degrees
Measured: 24 weeks
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Measured: 24 weeks
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Measured: 24 weeks
Secondary outcomes (31)
Patient Rated Wrist Evaluation
Measured: 2 weeks
Patient Rated Wrist Evaluation
Measured: 6 weeks
Patient Rated Wrist Evaluation
Measured: 12 weeks
Patient Rated Wrist Evaluation
Measured: 52 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Measured: 2 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Measured: 6 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Measured: 12 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Measured: 52 weeks
Pain Scale (on a scale from 1-10)
Measured: 2 weeks
Pain Scale (on a scale from 1-10)
Measured: 6 weeks
Pain Scale (on a scale from 1-10)
Measured: 12 weeks
Pain Scale (on a scale from 1-10)
Measured: 52 weeks
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Measured: 2 weeks
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Measured: 6 weeks
Radiographic evidence of healing
Do the x-rays show evidence of bone healing? Yes/No
Measured: 12 weeks
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Measured: 2 weeks
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Measured: 6 weeks
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Measured: 12 weeks
Complications that required further medical attention
Were there any complications that required further medical attention within the first 6 month after surgery?
Measured: 52 weeks
Range of Motion measured in degrees
Measured: 2 weeks
Range of Motion measured in degrees
Measured: 6 weeks
Range of Motion measured in degrees
Measured: 12 weeks
Range of Motion measured in degrees
Measured: 52 weeks
Grip Strength measured in kilograms
Measured: 2 weeks
Grip Strength measured in kilograms
Measured: 6 weeks
Grip Strength measured in kilograms
Measured: 12 weeks
Grip Strength measured in kilograms
Measured: 52 weeks
Pinch Strength measured in kilograms
Measured: 2 weeks
Pinch Strength measured in kilograms
Measured: 6 weeks
Pinch Strength measured in kilograms
Measured: 12 weeks
Pinch Strength measured in kilograms
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion19 Apr 2020
- Study completion19 Apr 2020
Why it stopped: Not enough study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Hoekzema, MD, Principal investigator, UCSF - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802774
- Sponsor's protocol ID
- 2016033
- Status last verified
- Mar 2021
- First submitted
- 2 Jun 2016
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will not share any individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immobilization of Postoperative Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02802774
- Acronym / sponsor ID
- 2016033
- Conditions
- Distal Radius Fractures
- Keywords
- Post-operative treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough study participants
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 19 Apr 2020 (actual)
- First posted
- 16 Jun 2016 (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 management of distal radius fractures has been in a state of evolution over the past 30 years. Treatment has become increasingly focused on obtaining a stable, internal construct for quick return to normal, daily activities. With the advent of volar locking plates, the wrist fracture is stable before the patient leaves the operating room. As surgical plate and screw constructs become more stable, the need for casting and splinting may be less.
The presumptive "next step" in operative management of distal radius fractures is to do away with the postoperative splint. A review of the available English language literature failed to reveal any studies evaluating the use of postoperative splinting and patient outcomes.
This prospective, randomized study was designed to investigate the use of temporary plaster splints versus removable over-the-counter splits versus soft dressings for post-operative treatment of extra-articular and intra-articular distal radius fractures. The patients will be followed for 12 months evaluating maintenance of fracture reduction and patient outcomes.
Detailed description
A prospective study using multiple surgeons at multiple centers (Community Regional Medical Center and Sierra Pacific Orthopaedic Center) investigating post-operative management of extra and intra articular distal radius fractures treated with volar locking plates. Post-operative management for 2 weeks immediately following surgery will consist of placing 1/3 of patients in a short arm, custom-made, plaster splint, 1/3 with a removable Velcro wrist splint, and 1/3 with a soft dressing. The Velcro wrist brace group will be asked to wear the brace as much as possible during the two weeks and the soft dressing may be removed by the patient on the third day after surgery.
- The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place.
- The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding.
- Patients in the soft dressing group will have non-stick gauze, 4x4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab.
Patients will be randomized using REDCap Randomization module after being consented to participate in the study by the primary investigator or sub-investigator. Each investigator will have the option during and/or after surgery to remove the patient from the group they have been randomized into and treat them as they see appropriate. These patients would be documented but removed from the study follow up.
Patient satisfaction will be evaluated subjectively with the PRWE (Patient-Rated Wrist Evaluation) as well as the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Radiographs will be taken at 2, 6, 12, and 24 weeks postoperatively to measure fracture alignment and healing. Patient reported pain level, range of motion, grip, and pinch strength will be recorded at each visit as well as at a final 1 year follow-up visit. Any complication will be noted. All of these visits are part of the standard of care. The only additional part of their visit would be the brief survey including the QuickDASH and PRWE that they complete with an orthopaedic surgery resident during their visit. In addition at the first follow up appointment at 2 weeks post-surgery, patients will be asked about their satisfaction with the mobility of their wrist and those in the Velcro brace will be asked how often they wore the brace. All data will be collected on a data collection sheet and then entered into a database
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plaster Splint | Active comparator | Other: Plaster Splint |
| Velcro Brace | Active comparator | Other: Velcro Brace |
| Soft Dressing | Active comparator | Other: Soft Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- extra and intra articular distal radius fractures treated with distal locking plates
Key exclusion criteria (1 listed)
- patients with additional injuries to the ipsilateral wrist such as, distal radial ulnar joint (DRUJ) instability and associated unstable ulna fractures.
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 |
|---|---|---|
| Plaster SplintThe custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place. Patients will wear the plaster splint for 2 weeks post-op. | Other | Plaster Splint |
| Velcro BraceThe Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding. Patients will be asked to wear the brace as much as possible for the first 2 weeks post-op. | Other | Velcro Brace |
| Soft DressingPatients in the soft dressing group will have non-stick gauze, 4X4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab. Patients wear the soft dressing for the first three days post-op. | Other | Soft Dressing |
Primary outcome
Patient Rated Wrist Evaluation
Time frame: 24 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time frame: 24 weeks
Pain Scale (on a scale from 1-10)
Time frame: 24 weeks
Grip Strength measured in kilograms
Time frame: 24 weeks
Pinch Strength measured in kilograms
Time frame: 24 weeks
Range of Motion measured in degrees
Time frame: 24 weeks
Radiographic evidence of healing
Time frame: 24 weeks
Do the x-rays show evidence of bone healing? Yes/No
Complications that required further medical attention
Time frame: 24 weeks
Were there any complications that required further medical attention within the first 6 month after surgery?
31 secondary outcomes
Patient Rated Wrist Evaluation
Time frame: 2 weeks
Patient Rated Wrist Evaluation
Time frame: 6 weeks
Patient Rated Wrist Evaluation
Time frame: 12 weeks
Patient Rated Wrist Evaluation
Time frame: 52 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time frame: 2 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time frame: 6 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time frame: 12 weeks
Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score
Time frame: 52 weeks
Pain Scale (on a scale from 1-10)
Time frame: 2 weeks
Pain Scale (on a scale from 1-10)
Time frame: 6 weeks
Pain Scale (on a scale from 1-10)
Time frame: 12 weeks
Pain Scale (on a scale from 1-10)
Time frame: 52 weeks
Radiographic evidence of healing
Time frame: 2 weeks
Radiographic evidence of healing
Time frame: 6 weeks
Radiographic evidence of healing
Time frame: 12 weeks
Complications that required further medical attention
Time frame: 2 weeks
Complications that required further medical attention
Time frame: 6 weeks
Complications that required further medical attention
Time frame: 12 weeks
Complications that required further medical attention
Time frame: 52 weeks
Range of Motion measured in degrees
Time frame: 2 weeks
Range of Motion measured in degrees
Time frame: 6 weeks
Range of Motion measured in degrees
Time frame: 12 weeks
Range of Motion measured in degrees
Time frame: 52 weeks
Grip Strength measured in kilograms
Time frame: 2 weeks
Grip Strength measured in kilograms
Time frame: 6 weeks
Grip Strength measured in kilograms
Time frame: 12 weeks
Grip Strength measured in kilograms
Time frame: 52 weeks
Pinch Strength measured in kilograms
Time frame: 2 weeks
Pinch Strength measured in kilograms
Time frame: 6 weeks
Pinch Strength measured in kilograms
Time frame: 12 weeks
Pinch Strength measured in kilograms
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Not enough study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No. We will not share any individual participant data.
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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.
Nathan Hoekzema, MD principal investigator
UCSF - Fresno
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaster Splint, Velcro Brace and Soft Dressing in people with Distal Radius Fractures, run by University of California, San Francisco at 2 sites in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 was stopped early (reason given: Not enough study participants). Results are not available in the source record.
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?
Patient Rated Wrist Evaluation (time frame: 24 weeks). The study lists 8 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 22 Mar 2021.