Distal Radius FractureNCT01589627
Wrist Extension Dynasplint (WED) Distal Radius Fracture
A study testing Wrist Extension Dynasplint in people with Distal Radius Fracture and Wrist Contracture, run by Dynasplint Systems, Inc..
Trial summary
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Radius Fracture, Wrist Contracture
- What is being tested?
- Wrist Extension Dynasplint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up
Who cannot join
- Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
- Radial nerve entrapment
- Arthrodesis
- Traumatic dislocation of the distal ulna
About this study
Official title: Contracture Reduction Following Distal Radius Fracture
The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.
- Conditions
- Distal Radius Fracture, Wrist Contracture
- Being tested
- Wrist Extension Dynasplint
- Keywords
- distal radius fracture, wrist contracture, dynasplint
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Extension DynasplintDevice
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Patients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint Receives: Device: Wrist Extension Dynasplint |
| Control | No intervention | Patients will receive standard of care physical therapy and NSAIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal active range of motion in wrist extension
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacy Berner, MD, Principal investigator, Advanced Centers for Orthopaedic Surgery and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589627
- Sponsor's protocol ID
- 2009.003
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2012
- Last updated
- 2 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contracture Reduction Following Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT01589627
- Acronym / sponsor ID
- 2009.003
- Conditions
- Distal Radius Fracture, Wrist Contracture
- Keywords
- distal radius fracture, wrist contracture, dynasplint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 May 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 purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Device: Wrist Extension DynasplintPatients will be treated with the Standard of Care physical therapy, NSAIDs as well as a Wrist Extension Dynasplint |
| Control | No intervention | –Patients will receive standard of care physical therapy and NSAIDS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up
Key exclusion criteria (4 listed)
- Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
- Radial nerve entrapment
- Arthrodesis
- Traumatic dislocation of the distal ulna
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 |
|---|---|---|
| Wrist Extension DynasplintDynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device. | Device | experimental |
Primary outcome
Change in maximal active range of motion in wrist extension
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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.
Stacy Berner, MD principal investigator
Advanced Centers for Orthopaedic Surgery and Sports Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Extension Dynasplint in people with Distal Radius Fracture and Wrist Contracture, run by Dynasplint Systems, Inc..
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 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: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in maximal active range of motion in wrist extension (time frame: 12 weeks). 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 2 May 2012.