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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fracture Neck of Femur, Hip Fracture, Femoral Neck Fracture

Intervention / Treatment
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* Procedure: Osteosynthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age 50 years and below<br>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<br>* 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<br>* Other names: Total hip replacement;|
| Age more than 50 years<br>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<br>* 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<br>* Other names: Total hip replacement;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fracture, Fracture neck femur, Osteosynthesis, Arthroplasty, Functional outcome