Hip FracturesEFFRA-65NCT04127045
ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
An observational study of Hip Fractures and Intertrochanteric Fractures, run by Biagio Moretti, MD at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Intertrochanteric Fractures, Femur Fracture
- What is being tested?
- IMN-Group and HA-Group
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2017to 31 Dec 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 in the Orthopedic and Trauma Unit of AOUC Policlinico di Bari were enrolled.
Who may be able to join
- age older than 65 years
- previous walking ability
- surgical procedure (intramedullary nailing or hemiarthroplasty)
Who cannot join
- neurological diseases
- musculoskeletal disorders
- cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, IT, 70124
About this study
Official title: ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
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 hip fractures. This study evaluates gait and mobility after surgical fixation of IT fractures in elderly population with Gait Analysis in combination with clinical and radiographic information.
Read the 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.
- Conditions
- Hip Fractures, Intertrochanteric Fractures, Femur Fracture
- Being tested
- IMN-Group, HA-Group
- Keywords
- gait analysis, hip fracture, elderly, mobility
- Medical subject headings
- Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMN-GroupProcedure or surgery
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.
HA-GroupProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| IMN-Group | Patients treated with intramedullary nailing Receives: Procedure: IMN-Group | |
| HA-Group | Patients treated with Hemiarthroplasty Receives: Procedure: HA-Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HHS at follow-up
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.
Measured: 12- months
Changes in WOMAC at follow-up
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.
Measured: 12- months
Changes in T-Score at follow-up
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.
Measured: 12- months
Changes in Spatial Parameters of Gait at follow-up
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).
Measured: 12- months
Changes in Temporal Parameters of Gait at follow-up
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 (%)
Measured: 12- months
Secondary outcomes (3)
Changes in ROM of Kinematic Angles
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.
Measured: 12- months
GGA-g Index
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.
Measured: 12- months
GGA-a Index
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.
Measured: 12- months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start2 Oct 2017
- Primary completion2 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biagio Moretti, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Biagio Moretti, MD, University of Bari
- Investigators
- Biagio Moretti, M.D., Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127045
- Sponsor's protocol ID
- 5559
- Acronym
- EFFRA-65
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33261299
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
- ClinicalTrials.gov ID
- NCT04127045
- Acronym / sponsor ID
- EFFRA-65 / 5559
- Conditions
- Hip Fractures, Intertrochanteric Fractures, Femur Fracture
- Keywords
- gait analysis, hip fracture, elderly, mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biagio Moretti, MDUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Oct 2019 (actual)
- 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.
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 hip fractures. This study evaluates gait and mobility after surgical fixation of IT fractures in elderly population with Gait Analysis in combination with clinical and radiographic information.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMN-Group | – | Procedure: IMN-GroupPatients treated with intramedullary nailing |
| HA-Group | – | Procedure: HA-GroupPatients treated with Hemiarthroplasty |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 in the Orthopedic and Trauma Unit of AOUC Policlinico di Bari were enrolled.
Key inclusion criteria (3 listed)
- age older than 65 years
- previous walking ability
- surgical procedure (intramedullary nailing or hemiarthroplasty)
Key exclusion criteria (3 listed)
- neurological diseases
- musculoskeletal disorders
- cardiovascular diseases
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 |
|---|---|---|
| IMN-GroupMost 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. | Procedure or surgery | IMN-Group |
| HA-GroupIn 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). | Procedure or surgery | HA-Group |
Primary outcome
Changes in HHS at follow-up
Time frame: 12- months
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.
Changes in WOMAC at follow-up
Time frame: 12- months
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.
Changes in T-Score at follow-up
Time frame: 12- months
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.
Changes in Spatial Parameters of Gait at follow-up
Time frame: 12- months
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).
Changes in Temporal Parameters of Gait at follow-up
Time frame: 12- months
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 (%)
3 secondary outcomes
Changes in ROM of Kinematic Angles
Time frame: 12- months
GGA-g Index
Time frame: 12- months
GGA-a Index
Time frame: 12- 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 8 Oct 2021.
- BackgroundBortone, 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.
- Results publication: PubMed 33261299Bizzoca 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Biagio Moretti, M.D. principal investigator
University of Bari
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 Hip Fractures and Intertrochanteric Fractures, run by Biagio Moretti, MD at 1 site in Italy.
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 3 inclusion and 3 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 8 Oct 2021. 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 Italy. 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?
Changes in HHS at follow-up (time frame: 12- months). The study lists 5 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 NCT04127045, which also lists 2 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 8 Oct 2021.