- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127045
ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population (EFFRA-65)
ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
Study Overview
Status
Intervention / Treatment
Detailed Description
Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after InterTrochanteric (IT) hip fractures. Improving gait and mobility after surgical fixation of IT fractures is one important target of research efforts.
All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 were enrolled. Inclusion criteria consisted of age older than 65 years, previous walking ability, no neurological disease and no other musculoskeletal disorders. The study was approved by the institutional review board of the Local Ethical Committee (reference number 5559). All patients provided written informed consent for participation in the study.
All patients were treated with intramedullary nailing (IMN) or hemiarthroplasty (HA) according to the current international guidelines and to their clinical history.
Radiographs were analyzed at the time of surgery and at each follow-up visit. Clinical outcomes were assessed according to the Harris Hip Score (HHS) and Western Ontario and Mc Master University (WOMAC).
At 6- and 12-months follow-up appointments, gait parameters were measured and recorded in our Gait Analysis Laboratory (BTS Bioengineering SpA, Italy) located in AOUC Policlinico di Bari (Rehabilitation Unit). All participants performed several walking trials at their natural speed. All patients were fitted with full-body external reflective markers placed according to Davis' procedures. A static video trial was recorded with subjects positioned in a neutral standing posture to create a reference for defining neutral joint angles.
In addition, at 12-months follow-up, dual energy X-ray absorptiometry (DXA) has been acquired in order to collect T-score data.
Statistical analyses were performed using IBM SPSS version 23. A p value of <0.05 was considered to be statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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IT
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Bari, IT, Italy, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age older than 65 years
- previous walking ability
- surgical procedure (intramedullary nailing or hemiarthroplasty)
Exclusion Criteria:
- neurological diseases
- musculoskeletal disorders
- cardiovascular diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IMN-Group
Patients treated with intramedullary nailing
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Most intertrochanteric fractures are managed with an intramedullary nail, which allows for impaction at the fracture site.
The intramedullary nail is placed directly into the marrow canal of the bone through an opening made at the top of the greater trochanter.
A lag screw is then placed through the nail and up into the neck and head of the hip.
As with the compression hip screw, sliding of the lag screw and impaction of the fracture take place.
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HA-Group
Patients treated with Hemiarthroplasty
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In the older patient, the chance that the head of the femur is damaged in this way is higher.
It is generally felt that for these displaced fractures, patients will do better if some of the components of the hip are replaced.
In some cases, this can mean a replacement of the ball, or head of the femur (hemiarthroplasty).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in HHS at follow-up
Time Frame: 12- months
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Harris Hip Score gives a maximum of 100 points.
Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points.
Function is subdivided into activities of daily living (14 points) and gait (33 points).
The higher the HHS, the less dysfunction.
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12- months
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Changes in WOMAC at follow-up
Time Frame: 12- months
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Western Ontario and Mc Master University Scale evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
The higher the score, the poorer the function.
Therefore, an improvement was achieved by reducing the overall score.
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12- months
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Changes in T-Score at follow-up
Time Frame: 12- months
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T-score is the relevant measure when screening for osteoporosis extracted from Dual energy X-ray Absorptiometry (DXA).
It is the bone mineral density (BMD) at the site when compared to the young normal reference mean.
A T-score between +1 and -1 is considered normal or healthy.
A T-score between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis.
A T-score of -2.5 or lower indicates that you have osteoporosis.
The greater the negative number, the more severe the osteoporosis.
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12- months
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Changes in Spatial Parameters of Gait at follow-up
Time Frame: 12- months
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Gait Analysis will be performed in two different time points and parameters related to spatial characteristics of gait during a gait cycle will be estimated: stride length (m), step length (m), step width (m).
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12- months
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Changes in Temporal Parameters of Gait at follow-up
Time Frame: 12- months
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Gait Analysis will be performed in two different time points and parameters related to temporal characteristics of gait during a gait cycle will be estimated (expressed in percentage): stance phase (%), swing phase (%)
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12- months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in ROM of Kinematic Angles
Time Frame: 12- months
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Gait Analysis will be performed in two different time points and the changes in ankle, knee, hip and pelvis angles (all measured in degree) will be estimated.
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12- months
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GGA-g Index
Time Frame: 12- months
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Gait Analysis will be performed in two different time points and an overall index of asymmetry (Global Gait Asymmetry) during the gait cycle will be estimated.
The higher the index, the higher the asymmetry between body part.
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12- months
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GGA-a Index
Time Frame: 12- months
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Gait Analysis will be performed in two different time points and an index of asymmetry (Global Gait Asymmetry) during the gait cycle in each kinematic angles (ankle, knee, hip and pelvis) will be estimated.
The higher the index, the higher the asymmetry between body part.
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12- months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Biagio Moretti, M.D., University of Bari
Publications and helpful links
General Publications
- Bortone, I., Caringella, N., Lelli, G., Rifino, F., Di Candia, A., Fiore, P., & Moretti, B. (2018). Effective mobility recovery after femoral neck fractures: The necessity of gait analysis in the immediate post-operative aftercare. Gait & Posture, 66, S7.
- Bizzoca D, Bortone I, Vicenti G, Caringella N, Rifino F, Moretti B. Gait analysis in the postoperative assessment of intertrochanteric femur fractures. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4 Suppl. 3):345-351. Congress of the Italian Orthopaedic Research Society.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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