Rib FractureNCT00556543
Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
A study testing U-plate fracture repair system in people with Rib Fracture and Flail Chest, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to gather information about a device used to help fix broken ribs. Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture, Flail Chest
- What is being tested?
- U-plate fracture repair system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Oct 2008
- 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
- Subjects must be at least 18 years of age
- Subjects must have one of the four clinical indications listed below:
- Flail chest with failure to wean from ventilator (> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury
- Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries
- Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax
- Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury
Who cannot join
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Subjects who are unable to complete the follow-up questionnaires
- Subjects with severe head injuries or other severe associated injuries
- Subjects who are not expected to survive the follow-up period
- Female subjects who are pregnant
- Non-English or English as Second Language speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures
The purpose of this study is to gather information about a device used to help fix broken ribs.
Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.
Read the detailed description
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery.
The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary.
With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself.
- Conditions
- Rib Fracture, Flail Chest
- Being tested
- U-plate fracture repair system
- Keywords
- Rib Fracture, Rib Fracture Repair, Rib Fracture ORIF, Flail Chest, Implant, Prosthesis, Rib fracture non-union, Chest wall deformity
- Medical subject headings
- Rib Fractures, Flail Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-plate fracture repair systemDevice
All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Not described Receives: Device: U-plate fracture repair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Post-op Events Related to the Repair and Plating System
Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
Measured: 180 days
The Rand 36-Item Health Survey Results - Physical Functioning Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Vitality Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Emotional Well-being Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Social Functioning Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - Bodily Pain Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The Rand 36-Item Health Survey Results - General Health Scale
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)
The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)
The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.
Measured: results at 60, 120, and 180 days post-repair with results posted for 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionOct 2008
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rib FractureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- ACUTE Innovations, LLC
- Investigators
- John C. Mayberry, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556543
- Sponsor's protocol ID
- IRB 579
- Other IDs
- eIRB00000579
- Status last verified
- Jun 2011
- First submitted
- 9 Nov 2007
- Last updated
- 1 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. doi: 10.1097/00005373-200002000-00023. No abstract available.
PubMed 10697096Beal SL, Oreskovich MR. Long-term disability associated with flail chest injury. Am J Surg. 1985 Sep;150(3):324-6. doi: 10.1016/0002-9610(85)90071-6.
PubMed 4037191Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
PubMed 11956391Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. doi: 10.1016/s0020-1383(01)00017-1. No abstract available.
PubMed 11587704
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures
- ClinicalTrials.gov ID
- NCT00556543
- Acronym / sponsor ID
- IRB 579
- Conditions
- Rib Fracture, Flail Chest
- Keywords
- Rib Fracture, Rib Fracture Repair, Rib Fracture ORIF, Flail Chest, Implant, Prosthesis, Rib fracture non-union, Chest wall deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- ACUTE Innovations, LLC
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 10 May 2011
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 gather information about a device used to help fix broken ribs.
Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.
Detailed description
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery.
The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary.
With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: U-plate fracture repair system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be at least 18 years of age
- Subjects must have one of the four clinical indications listed below:
Key exclusion criteria (7 listed)
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Subjects who are unable to complete the follow-up questionnaires
- Subjects with severe head injuries or other severe associated injuries
- Subjects who are not expected to survive the follow-up period
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 |
|---|---|---|
| U-plate fracture repair systemAll subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery. | Device | Treatment |
Primary outcome
Adverse Post-op Events Related to the Repair and Plating System
Time frame: 180 days
Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
The Rand 36-Item Health Survey Results - Physical Functioning Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Vitality Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Emotional Well-being Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Social Functioning Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - Bodily Pain Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The Rand 36-Item Health Survey Results - General Health Scale
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.
The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)
Time frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10697096Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. doi: 10.1097/00005373-200002000-00023. No abstract available.
- Background: PubMed 4037191Beal SL, Oreskovich MR. Long-term disability associated with flail chest injury. Am J Surg. 1985 Sep;150(3):324-6. doi: 10.1016/0002-9610(85)90071-6.
- Background: PubMed 11956391Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
- Background: PubMed 11587704Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. doi: 10.1016/s0020-1383(01)00017-1. No abstract available.
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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.
John C. Mayberry, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-plate fracture repair system in people with Rib Fracture and Flail Chest, run by Oregon Health and Science 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jul 2011. 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 10 May 2011). 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?
Adverse Post-op Events Related to the Repair and Plating System (time frame: 180 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556543, which also lists 4 linked publications.
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 1 Jul 2011.