Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879472
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-05-01
Brief Title:
Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Sponsor:
University of Nairobi
Organization:
University of Nairobi
Study Overview
Official Title:
Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a prospective cohort study The study was conducted in the two hospitals after approval by the KNHUON ethical committee and the board of management of Kikuyu Mission Hospital Trained data clerks were used for retrieval of data from the respective hospitals with follow-up conducted in the respective clinics and through phone calls The clerks were not blinded to the study but every data was corroborated by interviewing the patients or their relatives and evaluation of medical data availed as well as clinical status Both KNH and Kikuyu Mission Hospitals had handwritten patient notesrecords at the time of the study not electronic with central registries for storage of patient files The patients files and other medical documents will be available in the wards but upon discharge stored at the central registries
The WOMAC scoresassessment of the outcome measures were conducted by the principal investigator by direct interview of the patients their designated next of kin or via telephone contacts The outcome measures included pain stiffness and activities of daily living
The WOMAC scoresassessment of the outcome measures were conducted by the principal investigator by direct interview of the patients their designated next of kin or via telephone contacts The outcome measures included pain stiffness and activities of daily living
Detailed Description:
This was a prospective cohort study
The study was conducted in the two hospitals after approval by the Kenyatta National Hospital KNHUniversity of Nairobi UON ethical committee and the board of management of Kikuyu Mission Hospital KMH Trained data clerks were used for retrieval of data from the respective hospitals with follow-up conducted in the respective clinics and through phone calls The clerks were not blinded to the study but every data was corroborated by interviewing the patients or their relatives and evaluation of medical data availed as well as clinical status Both KNH and Kikuyu Mission Hospitals had handwritten patient notesrecords at the time of the study not electronic Both institutions respectively maintained central registries for storage of patient files following discharge from inpatient care At the time of the study this were a hybrid of electronic and manual data storage systems as the electronic system was being introduced The patients files and other medical documents will be available in the wards but upon discharge stored at the central registries
The Western Ontario and MacMaster Universities Osteoarthritis Index WOMAC scores were conducted by the principal investigator by direct interview of the patients their designated next of kin or via telephone contacts This was for the assessment of the outcome measures that included pain stiffness and activities of daily living The measures were accessed for the period within two weeks before injury for the pre-injury functional status and at three months after injury for the early functional status
This study has been completed and results available
The study was conducted in the two hospitals after approval by the Kenyatta National Hospital KNHUniversity of Nairobi UON ethical committee and the board of management of Kikuyu Mission Hospital KMH Trained data clerks were used for retrieval of data from the respective hospitals with follow-up conducted in the respective clinics and through phone calls The clerks were not blinded to the study but every data was corroborated by interviewing the patients or their relatives and evaluation of medical data availed as well as clinical status Both KNH and Kikuyu Mission Hospitals had handwritten patient notesrecords at the time of the study not electronic Both institutions respectively maintained central registries for storage of patient files following discharge from inpatient care At the time of the study this were a hybrid of electronic and manual data storage systems as the electronic system was being introduced The patients files and other medical documents will be available in the wards but upon discharge stored at the central registries
The Western Ontario and MacMaster Universities Osteoarthritis Index WOMAC scores were conducted by the principal investigator by direct interview of the patients their designated next of kin or via telephone contacts This was for the assessment of the outcome measures that included pain stiffness and activities of daily living The measures were accessed for the period within two weeks before injury for the pre-injury functional status and at three months after injury for the early functional status
This study has been completed and results available
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None