- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868125
Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Kfar Saba, Israel, 4423505
- Meir Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pertrochanteric femur fracture, classified as AO-31-A
- Go through a closed reduction and internal fixation operation at the investigator's institution
Exclusion Criteria:
- patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
- Fluoroscopy imaging studies were not saved
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
OIne week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in neck shaft angle between intra-operative fluoroscopy and follow-up x ray imaging studies
Time Frame: one week
|
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.
|
one week
|
The need for reoperation
Time Frame: One week
|
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.
|
One week
|
Changes in neck length between intra-operative fluoroscopy and follow-up x ray imaging studies
Time Frame: One week
|
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.
|
One week
|
Changes in tip-apex distance between intra-operative fluoroscopy and follow-up x ray imaging studies
Time Frame: One week
|
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.
|
One week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Segal, MD, Meir Medical Center
Publications and helpful links
General 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.
- van 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.
- Segal 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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