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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture; Femoral Neck Fracture; Fracture Neck of Femur
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population included those patients 18 years of age and above who underwent operative treatment of displaced fracture neck of femur at either Kenyatta National Hospital or Kikuyu Mission Hospital during the study period with granted written informed consent; except those with 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; those non-ambulatory prior to injury and those with chronic pain syndrome and/ or chronic opioid use.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Total hip replacement; Hemiarthroplasty
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: Total hip replacement; Hemiarthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	duration of inpatient care	three months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Ochieng SR, Kingori J, Awori KO, Ating'a JEO. Recovery of pre-injury functional state following operative treatment of displaced femoral neck fractures; a prospective cohort study. Ann Med Surg (Lond). 2021 Aug 11;69:102682. doi: 10.1016/j.amsu.2021.102682. eCollection 2021 Sep.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2008
• Primary Completion (ACTUAL): May 11, 2009
• Study Completion (ACTUAL): May 11, 2009

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (ACTUAL): May 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Arthroplasty; Hip fracture; Functional outcome; Osteosynthesis; Fracture neck femur
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: UniNairobi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share the study protocol, methodology and findings with other researches
• IPD Sharing Time Frame: six years, renewable
• IPD Sharing Access Criteria: email contact to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No