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

NCT04879472 | Completed

• 1 other identifier: UniNairobi
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fracture Neck of Femur; Hip Fracture; Femoral Neck Fracture

Keywords

Hip fracture; Fracture neck femur; Osteosynthesis; Arthroplasty; Functional outcome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Length of hospital stay

  three months

Study Arms (2)

Age 50 years and below

1. Type of surgery (modality of treatment) either osteosynthesis, Hemiarthroplasty or Total hip replacement 2. Surgical approach either posterior, lateral or anterolateral 3. Type of anaesthesia either general or spinal 4. Presence or absence of comorbidities 5. Sex

Procedure: Osteosynthesis

Age more than 50 years

1. Type of surgery (modality of treatment) either osteosynthesis, Hemiarthroplasty or Total hip replacement 2. Surgical approach either posterior, lateral or anterolateral 3. Type of anaesthesia either general or spinal 4. Presence or absence of comorbidities 5. Sex

Procedure: Osteosynthesis

Interventions

Osteosynthesis PROCEDURE

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

Also known as: Hemiarthroplasty, Total hip replacement

Age 50 years and below; Age more than 50 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nairobi: lead

Related Publications (1)

• 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.

  PMID: 34429951 RESULT

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures

Interventions

Fracture Fixation, Internal; Hemiarthroplasty; Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• SEPHENIA R OCHIENG', MBChB, MMed, MCh.

  University of Nairobi

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 10, 2021
• Study Start: November 12, 2008
• Primary Completion: May 11, 2009
• Study Completion: May 11, 2009
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: six years, renewable
• Access Criteria: email contact to the principal investigator