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

NCT ID: NCT04879472

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-12
• Study Completion Date: 2009-05-11

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.

Conditions

Fracture Neck of Femur; Hip Fracture; Femoral Neck Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Osteosynthesis

Intervention Type: 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

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

Osteosynthesis

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Hemiarthroplasty; Total hip replacement

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nairobi

OTHER

Sponsor Role: lead

Responsible Party

Sephenia Raduma Ochieng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEPHENIA R OCHIENG', MBChB, MMed, MCh.

Role: PRINCIPAL_INVESTIGATOR

University of Nairobi

JOHN E O ATING'A, MBChB, MCh

Role: STUDY_DIRECTOR

University of Nairobi

KIRSTINGS A ONDIKO, MBChB, MMed, FCS

Role: STUDY_DIRECTOR

University of Nairobi

JOHN KINGORI, MBChB, MMed

Role: STUDY_DIRECTOR

University of Nairobi/ Kikuyu Mission Hospital

References

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.

Reference Type: RESULT

PMID: 34429951 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UniNairobi

Identifier Type: -

Identifier Source: org_study_id