Clinical trial NCT04879472: Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Official title: Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture Neck of Femur
Hip Fracture
Femoral Neck Fracture
Keywords: Hip fracture
Fracture neck femur
Osteosynthesis
Arthroplasty
Functional outcome
Lead sponsor: University of Nairobi
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: within two weeks of assessment
measure: Stiffness score
timeFrame: within two weeks of assessment
measure: Activities of daily living (ADL) score
timeFrame: within two weeks of assessment
Secondary outcomes:
measure: Length of hospital stay
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nairobi
name: SEPHENIA R OCHIENG', MBChB, MMed, MCh.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nairobi
name: JOHN E O ATING'A, MBChB, MCh
role: STUDY_DIRECTOR
affiliation: University of Nairobi
name: KIRSTINGS A ONDIKO, MBChB, MMed, FCS
role: STUDY_DIRECTOR
affiliation: University of Nairobi/ Kikuyu Mission Hospital
name: JOHN KINGORI, MBChB, MMed
role: STUDY_DIRECTOR
References:
citation: 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.