Upper Extremity FractureJASNCT00580866
Progressive Splinting Status Post Elbow Fractures and Dislocations
A study testing JAS Brace in people with Upper Extremity Fracture and Upper Extremity Dislocation, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted
- What is being tested?
- JAS Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
- Agrees to participate and signs informed consent
- English Speaking (outcome questionnaires are validated for English only)
Who cannot join
- Less than 18 years of age
- Closed Head Injury
- Burn Injuries
- Ipsilateral upper extremity fracture(s) requiring surgery
- Nonunion of prior distal humerus fracture or fracture dislocation
- Type 3 open distal humerus fracture dislocation
Show all 10Show fewer
- Insufficient fracture fixation to allow early range of motion
- Transient population with no fixed address
- Not willing to sign informed consent
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8774
About this study
Official title: Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
Read the detailed description
Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.
We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.
Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.
The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.
- Conditions
- Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted, Elbow Fracture, Elbow Dislocation
- Being tested
- JAS Brace
- Keywords
- Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Dislocations, Peri-articular Elbow Injuries
- Medical subject headings
- Fractures, Comminuted, Elbow Fractures, Elbow Injuries, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAS BraceDevice
Also called JAS Static Progressive Stretch, Joint Active Systems Brace (JAS Brace), Static Stretching Brace, Static Progressive Stretching Brace
For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Joint Active Systems Brace (JAS Brace) | Experimental | Elbow is placed in a brace to apply an extension force Receives: Device: JAS Brace |
| PT Only Group | No intervention | No brace is used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow ROM at 12 Months
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
Secondary outcomes (1)
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )
Measured: 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Extremity 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Obremskey, Vanderbilt University
- Investigators
- William T Obremskey, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580866
- Sponsor's protocol ID
- 051196
- Acronym
- JAS
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2007
- Last updated
- 7 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
- ClinicalTrials.gov ID
- NCT00580866
- Acronym / sponsor ID
- JAS / 051196
- Conditions
- Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted, Elbow Fracture, Elbow Dislocation
- Keywords
- Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Dislocations, Peri-articular Elbow Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 7 Sep 2016
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 help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
Detailed description
Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries.
We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage.
Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain.
The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint Active Systems Brace (JAS Brace) | Experimental | Device: JAS BraceElbow is placed in a brace to apply an extension force |
| PT Only Group | No intervention | –No brace is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
- Agrees to participate and signs informed consent
- English Speaking (outcome questionnaires are validated for English only)
Key exclusion criteria (10 listed)
- Less than 18 years of age
- Closed Head Injury
- Burn Injuries
- Ipsilateral upper extremity fracture(s) requiring surgery
- Nonunion of prior distal humerus fracture or fracture dislocation
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 |
|---|---|---|
| JAS BraceAlso: JAS Static Progressive Stretch, Joint Active Systems Brace (JAS Brace), Static Stretching Brace, Static Progressive Stretching BraceFor approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week. | Device | Joint Active Systems Brace (JAS Brace) |
Primary outcome
Elbow ROM at 12 Months
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
1 secondary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 12 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William T Obremskey, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JAS Brace in people with Upper Extremity Fracture and Upper Extremity Dislocation, run by Vanderbilt University at 1 site 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 4 inclusion and 10 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 7 Sep 2016. 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 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?
Yes. Results are posted in the registry (first posted 7 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Elbow ROM at 12 Months (time frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively). 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 7 Sep 2016.