Hip FracturesNCT02272972
Performance Improvement Program on Imaging II
An observational study of Hip Fractures and Femoral Fractures, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 4 countries.
Trial summary
This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Femoral Fractures, Fractures, Bone
- What is being tested?
- Application of knowledge
- How many people
- 250 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Oct 2014to May 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
Who may be able to join
- Age 18 years and older
- Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)
- Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNA-II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN)
- For the prospective part of the study:
- Informed consent obtained, i.e.:
- Ability to understand the content of the patient information/Informed Consent Form
- Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)
- Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent
Who cannot join
- For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Switzerland2 sites
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, 8401
Municipal Hospital Triemli
Zurich, Canton of Zurich, 8063
United States1 site
University of Missouri Hospital and Clinics
Columbia, Missouri, 65212
About this study
This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation.
At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.
Read the detailed description
5 surgeons in 5 clinics will participate including a total of 125 prospective and 125 retrospective cases. This means 25+25 cases per clinic or 5+5 cases treated by each surgeon. The anonymized images of the surgeon's last 5 patients (retrospective part) and the pseudonymized images of the next 5 patients meeting the eligibility criteria (prospective part) will be assessed. Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
Individually, the 5 surgeons per clinic review the 25 postimplant intraoperative lateral images filed for 5 retrospective cases using a set of predefined criteria.
After this first assessment of retrospective cases, the group watches a video and a poster and has one hour of time to discuss it. The group reviews the 25 cases from the pre-education step again within a period of maximum 5 days. The data are analyzed at AO Clinical Investigation and Documentation (AOCID) and provided to the surgeons for data review meeting where they agree on areas for improvement and set target goals for the prospective series. For the whole period of the second assessment and the prospective series, the poster is placed in the area of the operating room.
After patient information/consent, eligible patients are included into the prospective part of the study and treated with either an intramedullary nail or a DHS. During the surgery, the surgeons use the newly achieved knowledge to record images.
In the next step, the 5 surgeons per clinic review individually 25 postimplant intraoperative lateral images of 5 prospective cases using the same set of predefined criteria. The data are analyzed at AOCID and review by the Imaging Working Group of AO Education.
The data are not transferred between the clinics. The main outcomes will be assessed based on the "Questionnaire for the assessment of the lateral intraoperative view of the proximal femur".
This questionnaire consists of seven questions, on image quality (Q1 and Q2; part A) and on quality of reduction and surgery (Q3 - Q7; part B). Q1 and Q2 allow only "yes/no" answers, with an option to comment on the answer "no". Q3 to Q5 are based on anatomical assessments and Q6 and Q7 ask for evaluation of the surgery. There is a "not assessable" answer option for all questions of part B.
- Conditions
- Hip Fractures, Femoral Fractures, Fractures, Bone
- Being tested
- Application of knowledge
- Keywords
- "fluoroscopy"[MeSH], "education, medical"[MeSH]
- Medical subject headings
- Hip Fractures, Femoral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of knowledgeOther
Educational Intervention has been performed at the treating surgeon (video and poster). The surgeons applies the achieved knowledge when performing the intraoperative fluoroscopy in patients with pertrochanteric fractures.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | One x-ray image per patient is assessed by the surgeon. The surgeon undergoes an educational intervention (video/poster) and applies the achieved knowledge during the second assessment of the same image. The intervention is not administered to patients, only to an image. | |
| Prosp.group (Application of knowledge) | No direct intervention at the patient. The surgeon applies the achieved knowledge during the performance of the fluoroscopy in the operating room. This image is assessed. Receives: Other: Application of knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment.
Measured: 6 months
Secondary outcomes (7)
Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2)
Measured: 6 months
Proportion of images that are rated as "not assessable" (Q3-Q7)
Measured: 6 months
Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7)
Measured: 6 months
Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7)
Measured: 6 months
Surgeons' experience (years and professional level)
Measured: 6 months
Surgeons practice (average number of hip surgeries per month)
Measured: 6 months
Self-assessment gap score
(3 questions regarding the current and the desired level of ability in fixing pertrochanteric femoral fractures, obtaining lateral intraoperative images of the proximal femur and assessing lateral intraoperative images of the proximal femur)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rikli, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272972
- Sponsor's protocol ID
- PI program II
- Status last verified
- Aug 2020
- First submitted
- 10 Oct 2014
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Heetveld MJ, Raaymakers EL, van Walsum AD, Barei DP, Steller EP. Observer assessment of femoral neck radiographs after reduction and dynamic hip screw fixation. Arch Orthop Trauma Surg. 2005 Apr;125(3):160-5. doi: 10.1007/s00402-004-0780-4. Epub 2005 Mar 2.
PubMed 15742193Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Sanders D, Schemitsch E, Guyatt GH. Interobserver reliability of classification systems to rate the quality of femoral neck fracture reduction. J Orthop Trauma. 2009 Jul;23(6):408-12. doi: 10.1097/BOT.0b013e31815ea017.
PubMed 19550226Rushton MN, Rushton VE, Worthington HV. The value of a quality improvement programme for panoramic radiography: a cluster randomised controlled trial. J Dent. 2013 Apr;41(4):328-35. doi: 10.1016/j.jdent.2012.12.009. Epub 2013 Jan 18.
PubMed 23337088Zisblatt L, Kues JR, Davis N, Willis CE. The long-term impact of a performance improvement continuing medical education intervention on osteoporosis screening. J Contin Educ Health Prof. 2013 Fall;33(4):206-14. doi: 10.1002/chp.21200.
PubMed 24347099Cannon CP, Hoekstra JW, Larson DM, Karcher RB, Mencia WA, Berry CA, Stowell SA. A report of quality improvement in the care of patients with acute coronary syndromes. Crit Pathw Cardiol. 2011 Mar;10(1):29-34. doi: 10.1097/HPC.0b013e318204eb8b.
PubMed 21562372Krettek C, Miclau T, Grun O, Schandelmaier P, Tscherne H. Intraoperative control of axes, rotation and length in femoral and tibial fractures. Technical note. Injury. 1998;29 Suppl 3:C29-39. doi: 10.1016/s0020-1383(98)95006-9.
PubMed 10341895
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Improvement Program on Imaging II
- ClinicalTrials.gov ID
- NCT02272972
- Acronym / sponsor ID
- PI program II
- Conditions
- Hip Fractures, Femoral Fractures, Fractures, Bone
- Keywords
- "fluoroscopy"[MeSH], "education, medical"[MeSH]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Oct 2014 (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 study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation.
At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.
Detailed description
5 surgeons in 5 clinics will participate including a total of 125 prospective and 125 retrospective cases. This means 25+25 cases per clinic or 5+5 cases treated by each surgeon. The anonymized images of the surgeon's last 5 patients (retrospective part) and the pseudonymized images of the next 5 patients meeting the eligibility criteria (prospective part) will be assessed. Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
Individually, the 5 surgeons per clinic review the 25 postimplant intraoperative lateral images filed for 5 retrospective cases using a set of predefined criteria.
After this first assessment of retrospective cases, the group watches a video and a poster and has one hour of time to discuss it. The group reviews the 25 cases from the pre-education step again within a period of maximum 5 days. The data are analyzed at AO Clinical Investigation and Documentation (AOCID) and provided to the surgeons for data review meeting where they agree on areas for improvement and set target goals for the prospective series. For the whole period of the second assessment and the prospective series, the poster is placed in the area of the operating room.
After patient information/consent, eligible patients are included into the prospective part of the study and treated with either an intramedullary nail or a DHS. During the surgery, the surgeons use the newly achieved knowledge to record images.
In the next step, the 5 surgeons per clinic review individually 25 postimplant intraoperative lateral images of 5 prospective cases using the same set of predefined criteria. The data are analyzed at AOCID and review by the Imaging Working Group of AO Education.
The data are not transferred between the clinics. The main outcomes will be assessed based on the "Questionnaire for the assessment of the lateral intraoperative view of the proximal femur".
This questionnaire consists of seven questions, on image quality (Q1 and Q2; part A) and on quality of reduction and surgery (Q3 - Q7; part B). Q1 and Q2 allow only "yes/no" answers, with an option to comment on the answer "no". Q3 to Q5 are based on anatomical assessments and Q6 and Q7 ask for evaluation of the surgery. There is a "not assessable" answer option for all questions of part B.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | – | –One x-ray image per patient is assessed by the surgeon. The surgeon undergoes an educational intervention (video/poster) and applies the achieved knowledge during the second assessment of the same image. The intervention is not administered to patients, only to an image. |
| Prosp.group (Application of knowledge) | – | Other: Application of knowledgeNo direct intervention at the patient. The surgeon applies the achieved knowledge during the performance of the fluoroscopy in the operating room. This image is assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible if they are at least 18 years old, have an AO 31-A1, A2 or A3 fracture and were treated with either a Proximal Femoral nail Antirotation (PFNA), a PFNA- II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN).
Key inclusion criteria (8 listed)
- Age 18 years and older
- Diagnosis of a pertrochanteric femoral fracture (AO 31-A1, A2, A3)
- Surgical treatment with either a Proximal Femoral Nail Antirotation (PFNA), a PFNA-II, a Dynamic Hip Screw (DHS) or a Titanium Trochanteric Fixation Nail System (TFN)
- Ability to understand the content of the patient information/Informed Consent Form
- Willingness to allow the use of health-related data (images) according to the Clinical Investigation Plan (CIP)
Key exclusion criteria (1 listed)
- For the prospective part of the study: - Mentally handicapped patients or patients with dementia that are not able to understand the content patient information/Informed Consent Form
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 |
|---|---|---|
| Application of knowledgeEducational Intervention has been performed at the treating surgeon (video and poster). The surgeons applies the achieved knowledge when performing the intraoperative fluoroscopy in patients with pertrochanteric fractures. | Other | Prosp.group (Application of knowledge) |
Primary outcome
Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment.
Time frame: 6 months
7 secondary outcomes
Interrater agreement between pre-educational and post-educational assessment of image quality (Q1-Q2)
Time frame: 6 months
Proportion of images that are rated as "not assessable" (Q3-Q7)
Time frame: 6 months
Proportion of "Quality of reduction and surgery" criteria with the best possible assessment (yes/optimal) (Q3-Q7)
Time frame: 6 months
Interrater agreement between pre-educational and post-educational assessment of surgery's quality (Q3-Q7)
Time frame: 6 months
Surgeons' experience (years and professional level)
Time frame: 6 months
Surgeons practice (average number of hip surgeries per month)
Time frame: 6 months
Self-assessment gap score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 15742193Heetveld MJ, Raaymakers EL, van Walsum AD, Barei DP, Steller EP. Observer assessment of femoral neck radiographs after reduction and dynamic hip screw fixation. Arch Orthop Trauma Surg. 2005 Apr;125(3):160-5. doi: 10.1007/s00402-004-0780-4. Epub 2005 Mar 2.
- Background: PubMed 19550226Karanicolas PJ, Bhandari M, Walter SD, Heels-Ansdell D, Sanders D, Schemitsch E, Guyatt GH. Interobserver reliability of classification systems to rate the quality of femoral neck fracture reduction. J Orthop Trauma. 2009 Jul;23(6):408-12. doi: 10.1097/BOT.0b013e31815ea017.
- Background: PubMed 23337088Rushton MN, Rushton VE, Worthington HV. The value of a quality improvement programme for panoramic radiography: a cluster randomised controlled trial. J Dent. 2013 Apr;41(4):328-35. doi: 10.1016/j.jdent.2012.12.009. Epub 2013 Jan 18.
- Background: PubMed 24347099Zisblatt L, Kues JR, Davis N, Willis CE. The long-term impact of a performance improvement continuing medical education intervention on osteoporosis screening. J Contin Educ Health Prof. 2013 Fall;33(4):206-14. doi: 10.1002/chp.21200.
- Background: PubMed 21562372Cannon CP, Hoekstra JW, Larson DM, Karcher RB, Mencia WA, Berry CA, Stowell SA. A report of quality improvement in the care of patients with acute coronary syndromes. Crit Pathw Cardiol. 2011 Mar;10(1):29-34. doi: 10.1097/HPC.0b013e318204eb8b.
- Background: PubMed 10341895Krettek C, Miclau T, Grun O, Schandelmaier P, Tscherne H. Intraoperative control of axes, rotation and length in femoral and tibial fractures. Technical note. Injury. 1998;29 Suppl 3:C29-39. doi: 10.1016/s0020-1383(98)95006-9.
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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.
Daniel Rikli, MD principal investigator
University Hospital, Basel, Switzerland
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Femoral Fractures, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 4 countries.
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 8 inclusion and 1 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, United States, Austria, Slovenia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Image quality as determined by The proportion of "yes" answers to Q1 and Q2 in the post-educational assessment II compared to the proportion of "yes" answers to Q1 and Q2 pre-educational assessment. (time frame: 6 months). 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 NCT02272972, which also lists 6 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 13 Aug 2020.