Minimally Displaced Intra-articular Distal Radius FractureNCT01883063
Distal Radius Fracture - Treatment Comparison
A study testing Surgical Treatment and Non surgical Treatment (Cast or splint) in people with Minimally Displaced Intra-articular Distal Radius Fracture, run by Sonoma Orthopedic Products, Inc. at 3 sites in United States.
Trial summary
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Minimally Displaced Intra-articular Distal Radius Fracture
- What is being tested?
- Surgical Treatment and Non surgical Treatment (Cast or splint)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Dec 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture
- Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture
- Must be treated within the first 14 days of injury,
- Male or female greater than or equal to 65 years of age.
- Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
- Ability to understand and provide written authorization for use and disclosure of personal health information
- Fracture that can be treated closed with or without closed reduction
Who cannot join
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open fracture
- Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- Unstable distal radioulnar joint after fracture fixation
- Fractures where the transverse fracture line is less than 10mm from the distal radius joint surface
Show all 12Show fewer
- Artery or Nerve injury secondary to fracture
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Currently on worker's compensation
- Rheumatoid arthritis or other inflammatory arthropathies.
- History of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Missouri
Columbia, Missouri, 65211
John Peter Smith Hospital
Fort Worth, Texas, 76107
Cadence Health
Winfield, Illinois, 60190
About this study
Official title: PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.
- Being tested
- Surgical Treatment, Non surgical Treatment (Cast or splint)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical TreatmentDevice
Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
Non surgical Treatment (Cast or splint)Device
Patients will be treated for distal radius fractures non surgically with a cast or splint
| Study group | Role | What they receive |
|---|---|---|
| WRx™ Intramedullary Nail | Experimental | Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture. Receives: Device: Surgical Treatment |
| Non surgical treatment (Cast) | Active comparator | Patients in this arm of the study will be treated with a cast for their wrist fracture. Receives: Device: Non surgical Treatment (Cast or splint) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Patient Outcomes Over Time
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
Measured: Data will be collected at 2, 6, 12, 26, 52 weeks
Secondary outcomes (1)
Change in Composite Functional Outcomes Over Time
Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.
Measured: Data will be collected at 2, 6, 12, 26, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Displaced Intra-articular 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonoma Orthopedic Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883063
- Sponsor's protocol ID
- WRx-001
- Status last verified
- Apr 2015
- First submitted
- 14 Jun 2013
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
- ClinicalTrials.gov ID
- NCT01883063
- Acronym / sponsor ID
- WRx-001
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sonoma Orthopedic Products, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2013 (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.
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WRx™ Intramedullary Nail | Experimental | Device: Surgical TreatmentPatients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture. |
| Non surgical treatment (Cast) | Active comparator | Device: Non surgical Treatment (Cast or splint)Patients in this arm of the study will be treated with a cast for their wrist fracture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture
- Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture
- Must be treated within the first 14 days of injury,
- Male or female greater than or equal to 65 years of age.
- Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
Key exclusion criteria (12 listed)
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open fracture
- Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- Unstable distal radioulnar joint after fracture fixation
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 |
|---|---|---|
| Surgical TreatmentPatients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail | Device | WRx™ Intramedullary Nail |
| Non surgical Treatment (Cast or splint)Patients will be treated for distal radius fractures non surgically with a cast or splint | Device | Non surgical treatment (Cast) |
Primary outcome
Change in Composite Patient Outcomes Over Time
Time frame: Data will be collected at 2, 6, 12, 26, 52 weeks
Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
1 secondary outcome
Change in Composite Functional Outcomes Over Time
Time frame: Data will be collected at 2, 6, 12, 26, 52 weeks
Results and safety
The study was stopped early (reason given: Low Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Treatment and Non surgical Treatment (Cast or splint) in people with Minimally Displaced Intra-articular Distal Radius Fracture, run by Sonoma Orthopedic Products, Inc. at 3 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 7 inclusion and 12 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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: Low Enrollment). 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 Composite Patient Outcomes Over Time (time frame: Data will be collected at 2, 6, 12, 26, 52 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 14 Apr 2015.