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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04879472
Other study ID # UniNairobi
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 12, 2008
Est. completion date May 11, 2009

Study information

Verified date May 2021
Source University of Nairobi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 11, 2009
Est. primary completion date May 11, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients 18 years of age and above who underwent operative treatment of displaced fracture neck of femur in the two institutions during the study period. - Written informed consent. Exclusion Criteria: - Patients who had un-displaced or bilateral fracture neck of femur, concomitant pelvic or lower limb fracture/ dislocation, multiple injuries, confusion, previous ipsilateral FNF or FNF surgery, operative treatment done outside the study setting, malignant/ pathological fractures or peri-prosthetic fractures; - Patients who were non-ambulatory prior to injury and those with chronic pain syndrome and/ or chronic opioid use; - Patients who declined to give written informed consent.

Study Design


Intervention

Procedure:
Osteosynthesis
The elderly are mainly treated by arthroplasty (total hip replacement or hemiarthroplasty) while the younger age groups, by osteosynthesis either using pins, screws or nails

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Nairobi

References & Publications (1)

Ochieng' S.R., Kingori J., Awori K.O., Ating'a J.E.O. Early Functional Outcome of Operative Treatment Of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres.

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score Pre-injury pain score in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index compared with three months' post-operative pain score. The scores are normalised into a scale of 0-100 with 100 indicating no pain and 0, worst pain disability. within two weeks of assessment
Primary Stiffness score Pre-injury Stiffness score in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index compared with three months' post-operative Stiffness score. The scores are normalised into a scale of 0-100 with 100 indicating no Stiffness disability and 0, worst stiffness disability within two weeks of assessment
Primary Activities of daily living (ADL) score Pre-injury Activities of Daily living(ADL) score in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index compared with three months' post-operative Activities of Daily living(ADL) score. The scores are normalised into a scale of 0-100 with 100 indicating best Activities of Daily living(ADL) and 0, poor performance in Activities of Daily living(ADL) within two weeks of assessment
Secondary Length of hospital stay duration of inpatient care three months
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