Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres

Hip Fracture Clinical Trial

Official title: Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres

Status Completed

Clinical Trial Summary

This was a prospective cohort study. The study was conducted in the two hospitals after approval by the KNH/UON 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 notes/records 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 scores(assessment 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.

Clinical Trial Description

This was a prospective cohort study.

The study was conducted in the two hospitals after approval by the Kenyatta National Hospital (KNH)/University 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 notes/records 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. ;

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fracture Neck of Femur
• Fractures, Bone
• Hip Fracture
• Hip Fractures

• NCT number: NCT04879472
• Study type: Observational [Patient Registry]
• Source: University of Nairobi
• Status: Completed
• Start date: November 12, 2008
• Completion date: May 11, 2009