Trial record 4 of 96 for:
Open Studies | "Hip Fractures"
Latin America Hip Fracture Mortality Study (LAMOS)
This study is currently recruiting participants.
Verified February 2013 by AO Clinical Investigation and Documentation
Sponsor:
AO Clinical Investigation and Documentation
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01650064
First received: July 6, 2012
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.
| Condition |
|---|
|
Hip Fractures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Latin America Hip Fracture Mortality Study |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- Death [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Harris Hip Score [ Time Frame: Screening/Preoperative and 90 ± 21 days ] [ Designated as safety issue: No ]
- Parker Mobility Score [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days ] [ Designated as safety issue: No ]
- Wound healing [ Time Frame: 30±7 days, 60±14 days, and 90± 21 days ] [ Designated as safety issue: No ]
- Fracture healing [ Time Frame: 60±14 days and 90± 21 days ] [ Designated as safety issue: No ]
- Anticipated surgical treatment-related adverse events [ Time Frame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ] [ Designated as safety issue: No ]
- EQ-5D [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with surgically-treated hip fracture in Latin America
Criteria
Inclusion Criteria:
- Adults 60 years and older
- Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation
- Primary surgical fracture treatment within 10 days after trauma
- No prior treatment for the fracture
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the clinical investigation according to the CIP
- Signed and dated IRB/EC-approved written informed consent
Exclusion Criteria:
- Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening)
- Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)
- Active malignancy
- Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2)
- Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression)
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Noncompletion of patient baseline questionnaires
- Prior implant on the fractured hip
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650064
Contacts
| Contact: Shandher Tovar, Dr.med | +51 997 511 008 | shandher.tovar@aofoundation.org |
| Contact: Denise Schmid | +41 44 200 2477 | denise.schmid@aofoundation.org |
Locations
| Argentina | |
| Hospital Italiano de Buenos Aires | Recruiting |
| Buenos Aires, Argentina | |
| Contact: Jorge Barla, MD | |
| Principal Investigator: Jorge Barla, MD | |
| Brazil | |
| Hospital Vila Velha | Not yet recruiting |
| Espirito Santo, Brazil | |
| Contact: Jose E Grandi Ribeiro Filho, MD | |
| Principal Investigator: Jose E Grandi Ribeiro Filho, MD | |
| IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo | Not yet recruiting |
| Passo Fundo, Brazil | |
| Contact: Luiz H Penteado da Silva, MD | |
| Principal Investigator: Luiz H Penteado da Silva, MD | |
| Hospital Municipal Miguel Couto | Not yet recruiting |
| Rio de Janeiro, Brazil | |
| Contact: Vincenzo Giordano, MD | |
| Principal Investigator: Vincenzo Giordano, MD | |
| Hospital das Clinicas da UNICAMP | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: William Belangero, MD | |
| Principal Investigator: William Belangero, MD | |
| Universidad de São Paulo | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Kodi E Kojima, MD | |
| Principal Investigator: Kodi E Kojima, MD | |
| Hospital São Paulo | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Helio J Alvachian Fernandes, MD | |
| Principal Investigator: Helio J Alvachian Fernandes, MD | |
| Hospital Irmandade da Santa Casa de Misericórdia de São Paulo | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Ralph W Christian, MD | |
| Principal Investigator: Ralph W Christian, MD | |
| Chile | |
| Hospital del Trabajador de Santiago | Not yet recruiting |
| Santiago, Chile | |
| Contact: Alejandro D Zylberberg Serman, MD | |
| Principal Investigator: Alejandro D Zylberberg Serman, MD | |
| Hospital Clínico Pontificia Universidad Católica de Chile | Not yet recruiting |
| Santiago, Chile | |
| Contact: Daniel A Schweitzer Fernández, MD | |
| Principal Investigator: Daniel A Schweitzer Fernández, MD | |
| Colombia | |
| Hospital Infantil de San José | Not yet recruiting |
| Bogotá, Colombia | |
| Contact: Carlos M Olarte Salazar, MD | |
| Principal Investigator: Carlos M Olarte Salazar, MD | |
| Costa Rica | |
| Hospital San Vicente de Paúl | Not yet recruiting |
| San José, Costa Rica | |
| Contact: Kenneth Barquero Blackshaw, MD | |
| Principal Investigator: Kenneth Barquero Blackshaw, MD | |
| Ecuador | |
| Hospital Teodoro Maldonado Carbo | Not yet recruiting |
| Guayaquil, Ecuador | |
| Contact: Miguel A Mite Vivar, MD | |
| Principal Investigator: Miguel A Mite Vivar, MD | |
| Mexico | |
| Hospital de Traumatología y Ortopedia "Lomas Verdes" | Not yet recruiting |
| Ciudad de México, Mexico | |
| Contact: Sergio A Oliva Ramirez, MD | |
| Principal Investigator: Sergio A Oliva Ramirez, MD | |
| Hospital de Traumatología y Ortopedia UMAE #21 | Not yet recruiting |
| Monterrey, Mexico | |
| Contact: José R Mendoza de la Cruz, MD | |
| Principal Investigator: José R Mendoza de la Cruz, MD | |
| Uruguay | |
| Asociación Española Primera de Socorros Mutuos | Recruiting |
| Montevideo, Uruguay | |
| Contact: Daniel H Rienzi Bergalli, MD | |
| Principal Investigator: Daniel H Rienzi Bergalli, MD | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
| Principal Investigator: | Wiliam Belangero, Dr.med | Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil |
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT01650064 History of Changes |
| Other Study ID Numbers: | LAMOS |
| Study First Received: | July 6, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by AO Clinical Investigation and Documentation:
|
Hip fracture Mortality |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 19, 2013