Pertrochanteric FractureNCT02868125
Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
An observational study of Pertrochanteric Fracture, run by Meir Medical Center at 1 site in Israel.
Trial summary
There is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pertrochanteric Fracture
- What is being tested?
- X ray radiography
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all ages who sustain a pertrochanteric femur fracture, classified as AO-31-A, and go through a closed reduction and internal fixation operation at the investigator's institution.
Who may be able to join
- Pertrochanteric femur fracture, classified as AO-31-A
- Go through a closed reduction and internal fixation operation at the investigator's institution
Who cannot join
- patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
- Fluoroscopy imaging studies were not saved
Trial locations and contacts
1 site in 1 country.
About this study
There is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. The policy in the investigator's institution as in other hospitals is to conduct a radiogram of the operated hip during the first days following operation after the patient bore weight on the fixated femur. The investigator's goal is to asses the added value of this policy and to offer recommendations regarding this specific followup component.
Read the detailed description
There is no consensus regarding the proper radiographic protocol following closed reduction and internal fixation of pertrochanteric femoral fractures. Despite its' questionable necessity and significant economic burden, many medical centers practice a policy of imaging internally fixated proximal femurs after the patients bore weight on them. The investigator's goal is to assess the added value of the postoperative imaging study described.
Materials and methods: We will conduct a prospective study. All patients who will be treated with closed reduction and internal fixation of AO31A fractures will be enrolled. Two sets of imaging studies will be assessed- the intra-operative AP and axial fluoroscopy studies and the radiograms that are taken following bearing weight on the operated hip. Three decision steps will take place regarding weight bearing limitations and a necessity for re-operation- (1) Immediately after the operation; (2) A day after the operation; (3) Following weight bearing according to a new radiogram. Objective measurements will be taken for each hip on both imaging modalities- neck-shaft angle, neck length and tip-apex distance.
- Conditions
- Pertrochanteric Fracture
- Being tested
- X ray radiography
- Keywords
- pertrochanteric, radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X ray radiographyRadiation
All studied patients will undergo an x-ray radiography of the operated hip. This protocol is a part of the investigators' common practice policy regardless of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight bearing instructions on follow up x ray imaging
During the few day following surgery a decision has to be made regarding weight bearing limitations on the operated hip. patients can be instructed to: (1) Full weight bearing, (2) Partial weight bearing, (3) Touch-down weight bearing, (4) Non weight bearing. This decision is primary taken according to the intra-operative fluoroscopy images, and revised a few days later after examining the first follow up x-ray imaging of the operated hip. The investigators wish to learn whether a new data from the first follow up imaging study leads to changes in weight bearing instructions. If a change was made due to new findings on follow up x-ray, then the case would be regarded as "change", while if no changes were made they would be regarded as "no change". Finally the investigators will calculate the number of patients that need to go through follow up x-ray imaging studies in order for one patient to have their weight bearing instructions changed.
Measured: OIne week
Secondary outcomes (4)
Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies
Neck-shaft angle is the angle between the femoral neck and femoral shaft, measured in degrees. The investigators wish to find whether there is a difference in the measurements' outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The angle described will be calculated on both modalities and compared, with the outcome being the difference in degrees.
Measured: one week
The need for reoperation
During the few day following surgery a decision has to be made regarding need for re-operation. This decision is primary taken according to the intra-operative fluoroscopy images, and revised a few days later after examining the first follow up x-ray imaging of the operated hip. The decision is based on both objective features such as nec-shaft angle, tip-apex index and neck length, and on subjective features such as the patients' basic medical functional status. The investigators wish to learn whether a new data from the first follow up imaging study leads to changes in the decision for re-operation. If a change was made due to new findings on follow up x-ray, then the case would be regarded as "change", while if no changes were made they would be regarded as "no change". Finally the investigators will calculate the number of patients that need to go through follow up x-ray imaging studies in order for one patient to be advised differently for re-operation.
Measured: One week
Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies
Neck length is the distance between the femoral neck base and the femoral head, and is measured in millimeters. The investigators wish to find whether there is a difference in the measurement outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The length described will be calculated on both modalities and compared, with the outcome being the difference in millimeters.
Measured: One week
Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies
Tip apex distance is the sum of the distances measured on both AP and axial studies between the proximal lag screw tip and the proximal femoral head border . It is measured by millimeters. The investigators wish to find whether there is a difference in the measurement outcome for the same patients on intra-operative fluoroscopy and on the first post-operative followup x-ray imaging studies. The length described will be calculated on both modalities and compared, with the outcome being the difference in millimeters.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pertrochanteric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David segal, MD, Meir Medical Center
- Investigators
- David Segal, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868125
- Sponsor's protocol ID
- 0172
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no data will be shared
Publications
Tufescu T. Working toward reducing postoperative fracture radiographs: a survey of Canadian surgeons. Can J Surg. 2016 Feb;59(1):26-8. doi: 10.1503/cjs.005715.
PubMed 26812405van Embden D, Stollenwerck GA, Koster LA, Kaptein BL, Nelissen RG, Schipper IB. The stability of fixation of proximal femoral fractures: a radiostereometric analysis. Bone Joint J. 2015 Mar;97-B(3):391-7. doi: 10.1302/0301-620X.97B3.35077.
PubMed 25737524Segal D, Palmanovich E, Faour A, Marom E, Feldman V, Yaacobi E, Slevin O, Kish B, Brin YS. Routine early post-operative X-ray following internal fixation of intertrochanteric femoral fractures is unjustified: a quality improvement study. J Orthop Surg Res. 2018 Jul 31;13(1):189. doi: 10.1186/s13018-018-0896-9.
PubMed 30064462
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
- ClinicalTrials.gov ID
- NCT02868125
- Acronym / sponsor ID
- 0172
- Conditions
- Pertrochanteric Fracture
- Keywords
- pertrochanteric, radiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Aug 2016 (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.
There is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. The policy in the investigator's institution as in other hospitals is to conduct a radiogram of the operated hip during the first days following operation after the patient bore weight on the fixated femur. The investigator's goal is to asses the added value of this policy and to offer recommendations regarding this specific followup component.
Detailed description
There is no consensus regarding the proper radiographic protocol following closed reduction and internal fixation of pertrochanteric femoral fractures. Despite its' questionable necessity and significant economic burden, many medical centers practice a policy of imaging internally fixated proximal femurs after the patients bore weight on them. The investigator's goal is to assess the added value of the postoperative imaging study described.
Materials and methods: We will conduct a prospective study. All patients who will be treated with closed reduction and internal fixation of AO31A fractures will be enrolled. Two sets of imaging studies will be assessed- the intra-operative AP and axial fluoroscopy studies and the radiograms that are taken following bearing weight on the operated hip. Three decision steps will take place regarding weight bearing limitations and a necessity for re-operation- (1) Immediately after the operation; (2) A day after the operation; (3) Following weight bearing according to a new radiogram. Objective measurements will be taken for each hip on both imaging modalities- neck-shaft angle, neck length and tip-apex distance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages who sustain a pertrochanteric femur fracture, classified as AO-31-A, and go through a closed reduction and internal fixation operation at the investigator's institution.
Key inclusion criteria (2 listed)
- Pertrochanteric femur fracture, classified as AO-31-A
- Go through a closed reduction and internal fixation operation at the investigator's institution
Key exclusion criteria (2 listed)
- patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
- Fluoroscopy imaging studies were not saved
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 |
|---|---|---|
| X ray radiographyAll studied patients will undergo an x-ray radiography of the operated hip. This protocol is a part of the investigators' common practice policy regardless of the study. | Radiation | – |
Primary outcome
Changes in weight bearing instructions on follow up x ray imaging
Time frame: OIne week
During the few day following surgery a decision has to be made regarding weight bearing limitations on the operated hip. patients can be instructed to: (1) Full weight bearing, (2) Partial weight bearing, (3) Touch-down weight bearing, (4) Non weight bearing. This decision is primary taken according to the intra-operative fluoroscopy images, and revised a few days later after examining the first follow up x-ray imaging of the operated hip. The investigators wish to learn whether a new data from the first follow up imaging study leads to changes in weight bearing instructions. If a change was made due to new findings on follow up x-ray, then the case would be regarded as "change", while if no changes were made they would be regarded as "no change". Finally the investigators will calculate the number of patients that need to go through follow up x-ray imaging studies in order for one patient to have their weight bearing instructions changed.
4 secondary outcomes
Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies
Time frame: one week
The need for reoperation
Time frame: One week
Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies
Time frame: One week
Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Background: PubMed 26812405Tufescu T. Working toward reducing postoperative fracture radiographs: a survey of Canadian surgeons. Can J Surg. 2016 Feb;59(1):26-8. doi: 10.1503/cjs.005715.
- Background: PubMed 25737524van Embden D, Stollenwerck GA, Koster LA, Kaptein BL, Nelissen RG, Schipper IB. The stability of fixation of proximal femoral fractures: a radiostereometric analysis. Bone Joint J. 2015 Mar;97-B(3):391-7. doi: 10.1302/0301-620X.97B3.35077.
- Derived from this study: PubMed 30064462Segal D, Palmanovich E, Faour A, Marom E, Feldman V, Yaacobi E, Slevin O, Kish B, Brin YS. Routine early post-operative X-ray following internal fixation of intertrochanteric femoral fractures is unjustified: a quality improvement study. J Orthop Surg Res. 2018 Jul 31;13(1):189. doi: 10.1186/s13018-018-0896-9.
- Individual participant dataSharing planned: No. no data will be shared
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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.
David Segal, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertrochanteric Fracture, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 Israel. 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?
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?
Changes in weight bearing instructions on follow up x ray imaging (time frame: OIne week). 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 NCT02868125, which also lists 3 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 16 Aug 2016.