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

Sponsor

University of Nairobi (Other)

Overall Status

Completed

CT.gov ID

NCT04879472

Collaborator

(none)

Enrollment

5.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fracture Neck of Femur Hip Fracture Femoral Neck Fracture	Procedure: Osteosynthesis

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 12, 2008

Actual Primary Completion Date :

May 11, 2009

Actual Study Completion Date :

May 11, 2009

Arms and Interventions

Arm	Intervention/Treatment
Age 50 years and below Type of surgery (modality of treatment) either osteosynthesis, Hemiarthroplasty or Total hip replacement Surgical approach either posterior, lateral or anterolateral Type of anaesthesia either general or spinal Presence or absence of comorbidities Sex	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 Other Names: Hemiarthroplasty Total hip replacement
Age more than 50 years Type of surgery (modality of treatment) either osteosynthesis, Hemiarthroplasty or Total hip replacement Surgical approach either posterior, lateral or anterolateral Type of anaesthesia either general or spinal Presence or absence of comorbidities Sex	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 Other Names: Hemiarthroplasty Total hip replacement

Arm

Intervention/Treatment

Age 50 years and below

Type of surgery (modality of treatment) either osteosynthesis, Hemiarthroplasty or Total hip replacement Surgical approach either posterior, lateral or anterolateral Type of anaesthesia either general or spinal Presence or absence of comorbidities Sex

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

Other Names:

Hemiarthroplasty

Total hip replacement

Age more than 50 years

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

Other Names:

Hemiarthroplasty

Total hip replacement

Outcome Measures

Primary Outcome Measures

Pain score [within two weeks of assessment]
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.
Stiffness score [within two weeks of assessment]
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
Activities of daily living (ADL) score [within two weeks of assessment]
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)

Secondary Outcome Measures

Length of hospital stay [three months]
duration of inpatient care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nairobi

Investigators

Principal Investigator: SEPHENIA R OCHIENG', MBChB, MMed, MCh., University of Nairobi
Study Director: JOHN E O ATING'A, MBChB, MCh, University of Nairobi
Study Director: KIRSTINGS A ONDIKO, MBChB, MMed, FCS, University of Nairobi
Study Director: JOHN KINGORI, MBChB, MMed, University of Nairobi/ Kikuyu Mission Hospital