Hip FracturesNCT03130673
Challenges of Hip Fracture Care in Developing Countries. Experience at a Level 3 Center in Panama
An observational study of Hip Fractures, run by Hospital del Niño "Dr. José Renán Esquivel" at 1 site in Panama.
Trial summary
An observational study using the information records at the Hospital Regional Rafael Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early treatments results of hip fracture patients treated in this institution. Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Hip Fractures
- How many people
- 104 participants
- Where
- 1 sitePanama
- Study dates
- 1 Sep 2014to 31 Dec 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 18 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All of the Hip fractures in Hospital Regional Rafael Hernandez from september 2014 until march 2015
Who may be able to join
- All hip fractures
Who cannot join
- All other fractures and no recorded survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hip Fracture Epidemiology at Hospital Regional Rafael Hernandez. September 2014 to March 2015.
An observational study using the information records at the Hospital Regional Rafael Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early treatments results of hip fracture patients treated in this institution.
Read the detailed description
Hip fractures are a major public health concern due to increasing ageing of the population, rising costs and associated morbidity and mortality. The problem is more serious in developing countries, because of limited economic and technical resources available. The aim of the following study is to analyze the epidemiology and early treatment results of hip fracture patients treated in our unit.
This study will be done at the Hospital Rafael Hernandez Regional Hospital, a third level facility located in the province of Chiriqui, Republic of Panama. It is a retrospective observational study.
For this the study will use the hospital records, including imaging studies were reviewed, including the Singh Index, and all relevant data will be analyzed with SPSS 21 software.
- Conditions
- Hip Fractures
- Keywords
- hip fracture, trochanteric fracure, subtrocantheric fracture, femoral head fracture, epidemiology
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hip fracture | fracture of proximal femur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical classified action of the Fracture
kind of proximal femoral fracture as sub trochanteric, intertrochanteric or subcapital
Measured: 6 months
Secondary outcomes (6)
Sex
male or female
Measured: 6 months
Age
years old of the patient when he or she has the fracture
Measured: 6 months
Comorbidities
Diseases of the patient (diabetes, hight blood pressure, others)
Measured: 6 months
Energy of Trauma
IF it was high energy or low energy trauma
Measured: 6 months
Average length of stay
Time frame that the patient stayed at the hospital
Measured: 6 months
Osteoporosis
Severe, mild, light
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 posted26 Apr 2017
- Study start1 Sep 2014
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Niño "Dr. José Renán Esquivel"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arizt De Leon Robles, Hospital del Niño "Dr. José Renán Esquivel"
- Investigators
- Arizt De Leon, MD, Principal investigator, orthopaedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130673
- Sponsor's protocol ID
- HRRH
- Status last verified
- Sep 2024
- First submitted
- 22 Apr 2017
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ethgen O, Tellier V, Sedrine WB, De Maeseneer J, Gosset C, Reginster JY. Health-related quality of life and cost of ambulatory care in osteoporosis: how may such outcome measures be valuable information to health decision makers and payers? Bone. 2003 Jun;32(6):718-24. doi: 10.1016/s8756-3282(03)00089-9.
PubMed 12810180Clark, P.; Chico, G.; Carlos F y cols (2013) Osteoporosis En América Latina: Revisión De Panel De Expertos. Medwave. 13(8):E5791
U.S. Census Bureau, (2011) International Data Base. Retrieved from http://www.census.gov/
Nacionales DC, Szpila B, Ungaro R, Lopez MC, Zhang J, Gentile LF, Cuenca AL, Vanzant E, Mathias B, Jyot J, Westerveld D, Bihorac A, Joseph A, Mohr A, Duckworth LV, Moore FA, Baker HV, Leeuwenburgh C, Moldawer LL, Brakenridge S, Efron PA. A Detailed Characterization of the Dysfunctional Immunity and Abnormal Myelopoiesis Induced by Severe Shock and Trauma in the Aged. J Immunol. 2015 Sep 1;195(5):2396-407. doi: 10.4049/jimmunol.1500984. Epub 2015 Aug 5.
PubMed 26246141Bank, I. (1994). Latin America in Graphs: Demographic and Economic Trends 1972-1992. Population And Development Review, 20(3), 677. http://dx.doi.org/10.2307/2137618.
Glenn, V. (2006). International Data Base (IDB) 2006, 188 International Data Base (IDB). URL: http://www.census.gov/ipc/www/idbnew.html: International Programs Center, US Census Bureau Last visited November 2005. Reference Reviews, 20(4), 19-19.
Chue de Coto E. [The incidence of hip fractures in pre- and postmenopausal women in Panama]. Rev Med Panama. 1997 Jan;22(1):30-8. Spanish.
PubMed 9805092Chue de Coto E. [Osteopenia and osteoporosis in postmenopausal women in Panama]. Rev Med Panama. 2000;25:34-7. Spanish.
PubMed 15881746Moja L, Piatti A, Pecoraro V, Ricci C, Virgili G, Salanti G, Germagnoli L, Liberati A, Banfi G. Timing matters in hip fracture surgery: patients operated within 48 hours have better outcomes. A meta-analysis and meta-regression of over 190,000 patients. PLoS One. 2012;7(10):e46175. doi: 10.1371/journal.pone.0046175. Epub 2012 Oct 3.
PubMed 23056256Zanchetta J, Macdonald S. (2012) The Latin America Regional Audit. Epidemiology, Costs & Burden Of Osteoporosis In 2012. Switzerland: International Osteoporosis Foundation.
Clark P, Carlos F, Vázquez-Martínez JL. (2010) Epidemiology, Costs And Burden Of Osteoporosis In Mexico. Arch Osteoporos. 5:9-17
Sandoval, Ricardo. Epidemiologia y Costos de las Fracturas de Cadera en egresados del Complejo Hospitalario Metropolitano De La Caja De Seguro Social, Año 1990.
Morales-Torres J, Gutierrez-Urena S; Osteoporosis Committee of Pan-American League of Associations for Rheumatology. The burden of osteoporosis in Latin America. Osteoporos Int. 2004 Aug;15(8):625-32. doi: 10.1007/s00198-004-1596-3. Epub 2004 Mar 20.
PubMed 15292978Etxebarria-Foronda I, Mar J, Arrospide A, Ruiz de Eguino J. [Cost and mortality associated to the surgical delay of patients with a hip fracture. Spain]. Rev Esp Salud Publica. 2013 Nov-Dec;87(6):639-49. doi: 10.4321/S1135-57272013000600008. Spanish.
PubMed 24549361von Friesendorff M, Besjakov J, Akesson K. Long-term survival and fracture risk after hip fracture: a 22-year follow-up in women. J Bone Miner Res. 2008 Nov;23(11):1832-41. doi: 10.1359/jbmr.080606.
PubMed 18597630
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Epidemiology at Hospital Regional Rafael Hernandez. September 2014 to March 2015.
- ClinicalTrials.gov ID
- NCT03130673
- Acronym / sponsor ID
- HRRH
- Conditions
- Hip Fractures
- Keywords
- hip fracture, trochanteric fracure, subtrocantheric fracture, femoral head fracture, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospital del Niño "Dr. José Renán Esquivel"University, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Apr 2017 (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.
An observational study using the information records at the Hospital Regional Rafael Hernandez, in Chiriqui, Panama, that will help to analyze the epidemiology and early treatments results of hip fracture patients treated in this institution.
Detailed description
Hip fractures are a major public health concern due to increasing ageing of the population, rising costs and associated morbidity and mortality. The problem is more serious in developing countries, because of limited economic and technical resources available. The aim of the following study is to analyze the epidemiology and early treatment results of hip fracture patients treated in our unit.
This study will be done at the Hospital Rafael Hernandez Regional Hospital, a third level facility located in the province of Chiriqui, Republic of Panama. It is a retrospective observational study.
For this the study will use the hospital records, including imaging studies were reviewed, including the Singh Index, and all relevant data will be analyzed with SPSS 21 software.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture | – | –fracture of proximal femur |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the Hip fractures in Hospital Regional Rafael Hernandez from september 2014 until march 2015
Key inclusion criteria (1 listed)
- All hip fractures
Key exclusion criteria (1 listed)
- All other fractures and no recorded survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anatomical classified action of the Fracture
Time frame: 6 months
kind of proximal femoral fracture as sub trochanteric, intertrochanteric or subcapital
6 secondary outcomes
Sex
Time frame: 6 months
Age
Time frame: 6 months
Comorbidities
Time frame: 6 months
Energy of Trauma
Time frame: 6 months
Average length of stay
Time frame: 6 months
Osteoporosis
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 2 Oct 2024.
- Background: PubMed 12810180Ethgen O, Tellier V, Sedrine WB, De Maeseneer J, Gosset C, Reginster JY. Health-related quality of life and cost of ambulatory care in osteoporosis: how may such outcome measures be valuable information to health decision makers and payers? Bone. 2003 Jun;32(6):718-24. doi: 10.1016/s8756-3282(03)00089-9.
- BackgroundClark, P.; Chico, G.; Carlos F y cols (2013) Osteoporosis En América Latina: Revisión De Panel De Expertos. Medwave. 13(8):E5791
- BackgroundU.S. Census Bureau, (2011) International Data Base. Retrieved from http://www.census.gov/
- Background: PubMed 26246141Nacionales DC, Szpila B, Ungaro R, Lopez MC, Zhang J, Gentile LF, Cuenca AL, Vanzant E, Mathias B, Jyot J, Westerveld D, Bihorac A, Joseph A, Mohr A, Duckworth LV, Moore FA, Baker HV, Leeuwenburgh C, Moldawer LL, Brakenridge S, Efron PA. A Detailed Characterization of the Dysfunctional Immunity and Abnormal Myelopoiesis Induced by Severe Shock and Trauma in the Aged. J Immunol. 2015 Sep 1;195(5):2396-407. doi: 10.4049/jimmunol.1500984. Epub 2015 Aug 5.
- BackgroundBank, I. (1994). Latin America in Graphs: Demographic and Economic Trends 1972-1992. Population And Development Review, 20(3), 677. http://dx.doi.org/10.2307/2137618.
- BackgroundGlenn, V. (2006). International Data Base (IDB) 2006, 188 International Data Base (IDB). URL: http://www.census.gov/ipc/www/idbnew.html: International Programs Center, US Census Bureau Last visited November 2005. Reference Reviews, 20(4), 19-19.
- Background: PubMed 9805092Chue de Coto E. [The incidence of hip fractures in pre- and postmenopausal women in Panama]. Rev Med Panama. 1997 Jan;22(1):30-8. Spanish.
- Background: PubMed 15881746Chue de Coto E. [Osteopenia and osteoporosis in postmenopausal women in Panama]. Rev Med Panama. 2000;25:34-7. Spanish.
- Background: PubMed 23056256Moja L, Piatti A, Pecoraro V, Ricci C, Virgili G, Salanti G, Germagnoli L, Liberati A, Banfi G. Timing matters in hip fracture surgery: patients operated within 48 hours have better outcomes. A meta-analysis and meta-regression of over 190,000 patients. PLoS One. 2012;7(10):e46175. doi: 10.1371/journal.pone.0046175. Epub 2012 Oct 3.
- BackgroundZanchetta J, Macdonald S. (2012) The Latin America Regional Audit. Epidemiology, Costs & Burden Of Osteoporosis In 2012. Switzerland: International Osteoporosis Foundation.
- BackgroundClark P, Carlos F, Vázquez-Martínez JL. (2010) Epidemiology, Costs And Burden Of Osteoporosis In Mexico. Arch Osteoporos. 5:9-17
- BackgroundSandoval, Ricardo. Epidemiologia y Costos de las Fracturas de Cadera en egresados del Complejo Hospitalario Metropolitano De La Caja De Seguro Social, Año 1990.
- Individual participant dataSharing planned: No
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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.
Arizt De Leon, MD principal investigator
orthopaedic surgeon
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, run by Hospital del Niño "Dr. José Renán Esquivel" at 1 site in Panama.
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 1 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 2 Oct 2024. 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 Panama. 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?
Anatomical classified action of the Fracture (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 NCT03130673, which also lists 45 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 2 Oct 2024.