Fracture Neck of FemurNCT04879472
Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
An observational study of Fracture Neck of Femur and Hip Fracture, run by University of Nairobi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Neck of Femur, Hip Fracture, Femoral Neck Fracture
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2008to 11 May 2009
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Osteosynthesis
- Keywords
- Hip fracture, Fracture neck femur, Osteosynthesis, Arthroplasty, Functional outcome
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Also called Hemiarthroplasty, Total hip replacement
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: within two weeks of assessment
Secondary outcomes (1)
Length of hospital stay
duration of inpatient care
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start12 Nov 2008
- Primary completion11 May 2009
- Study completion11 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture Neck of FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sephenia Raduma Ochieng, University of Nairobi
- Investigators
- SEPHENIA R OCHIENG', MBChB, MMed, MCh., Principal investigator, University of NairobiJOHN E O ATING'A, MBChB, MCh, Study director, University of NairobiKIRSTINGS A ONDIKO, MBChB, MMed, FCS, Study director, University of NairobiJOHN KINGORI, MBChB, MMed, Study director, University of Nairobi/ Kikuyu Mission Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879472
- Sponsor's protocol ID
- UniNairobi
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share the study protocol, methodology and findings with other researches
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.
PubMed 34429951
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
- ClinicalTrials.gov ID
- NCT04879472
- Acronym / sponsor ID
- UniNairobi
- Conditions
- Fracture Neck of Femur, Hip Fracture, Femoral Neck Fracture
- Keywords
- Hip fracture, Fracture neck femur, Osteosynthesis, Arthroplasty, Functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Study start
- 12 Nov 2008 (actual)
- Primary completion
- 11 May 2009 (actual)
- Study completion
- 11 May 2009 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 50 years and below | – | Procedure: Osteosynthesis1. 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 |
| Age more than 50 years | – | Procedure: Osteosynthesis1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteosynthesisAlso: Hemiarthroplasty, Total hip replacementThe elderly are mainly treated by arthroplasty (total hip replacement or hemiarthroplasty) while the younger age groups, by osteosynthesis either using pins, screws or nails | Procedure or surgery | Age 50 years and below, Age more than 50 years |
Primary outcome
Pain score
Time frame: within two weeks of assessment
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.
Stiffness score
Time frame: within two weeks of assessment
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
Activities of daily living (ADL) score
Time frame: within two weeks of assessment
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)
1 secondary outcome
Length of hospital stay
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Results publication: PubMed 34429951Ochieng 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.
- Individual participant dataSharing planned: Yes. Share the study protocol, methodology and findings with other researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEPHENIA R OCHIENG', MBChB, MMed, MCh. principal investigator
University of Nairobi
JOHN E O ATING'A, MBChB, MCh study director
University of Nairobi
KIRSTINGS A ONDIKO, MBChB, MMed, FCS study director
University of Nairobi
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Neck of Femur and Hip Fracture, run by University of Nairobi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: within two weeks of assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.