Wrist FractureNCT01293227
WRx Distal Radius Wrist Fracture Study
A study testing Surgical treatment of distal radius fractures in people with Wrist Fracture, run by Mayo Clinic at 1 site in United States.
Trial summary
This research project is a multi-year proposal, with the goals of answering and evaluating the following: 1. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wrist Fracture
- What is being tested?
- Surgical treatment of distal radius fractures
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following criteria must be met to be enrolled:
- Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
- Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture
- Be a male or non-pregnant female at least 18 years of age.
- Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- Have the ability to understand and provide written authorization for use and disclosure of personal health information
- Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side)
Who cannot join
- Subjects are excluded if:
- Have any of the following conditions
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open, multifragmentary fracture
- Unstable distal radioulnar joint after fracture fixation
Show all 15Show fewer
- Artery or Nerve injury secondary to fracture
- Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- Currently on chemotherapy or radiation therapy
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- History of uncontrolled diabetes
- History of active rheumatologic disease with deformity
- History of chronic pain issues, psychiatric disorder which precludes reliable follow-up
- Unable to provide consent for the study
- Unable to make the follow-up appointments required of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.
This research project is a multi-year proposal, with the goals of answering and evaluating the following:
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?
- Conditions
- Wrist Fracture
- Being tested
- Surgical treatment of distal radius fractures
- Keywords
- Wrist Fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of distal radius fracturesProcedure or surgery
Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain (to no pain)
Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain.
Measured: Baseline to week 52 after surgery
Secondary outcomes (2)
Change in range of motion measurements
Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.
Measured: Basline to week 52 after surgery
Grip and Pinch
Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.
Measured: Baseline to week 52 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Funding was withdrawn due to inadequete enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FractureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Alexander Shin, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293227
- Sponsor's protocol ID
- 10-005213
- Status last verified
- Jan 2012
- First submitted
- 4 Feb 2011
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01293227
- Acronym / sponsor ID
- 10-005213
- Conditions
- Wrist Fracture
- Keywords
- Wrist Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was withdrawn due to inadequete enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Feb 2011 (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 research project is a multi-year proposal, with the goals of answering and evaluating the following:
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
- Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture
- Be a male or non-pregnant female at least 18 years of age.
- Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- Have the ability to understand and provide written authorization for use and disclosure of personal health information
Key exclusion criteria (15 listed)
- Have any of the following conditions
- Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
- Currently on chemotherapy or radiation therapy
- History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- History of uncontrolled diabetes
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 treatment of distal radius fracturesSurgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate | Procedure or surgery | – |
Primary outcome
Change in Pain (to no pain)
Time frame: Baseline to week 52 after surgery
Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain.
2 secondary outcomes
Change in range of motion measurements
Time frame: Basline to week 52 after surgery
Grip and Pinch
Time frame: Baseline to week 52 after surgery
Results and safety
The study was stopped early (reason given: Funding was withdrawn due to inadequete enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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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.
Alexander Shin, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of distal radius fractures in people with Wrist Fracture, run by Mayo Clinic 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 7 inclusion and 15 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 24 Jan 2012. 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?
The study was stopped early (reason given: Funding was withdrawn due to inadequete 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 Pain (to no pain) (time frame: Baseline to week 52 after surgery). 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 24 Jan 2012.