Femoral Neck FractureEXVALNCT02362971
External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture
An observational study of Femoral Neck Fracture and Hip Fracture, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced femoral neck fracture. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fracture, Hip Fracture
- How many people
- 900 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: A femoral neck fracture in the elderly patient is a common cause of suffering and premature death in an aging population. Femoral neck fractures are mainly a fragility (osteoporotic) fracture, predominantly affecting women after menopause. Included in the study are elderly patients (>80 years) with a displaced femoral neck fracture.
Who may be able to join
- Age above 80 years
- Acute (<36h) displaced femoral neck fracture.
- Independent walker
- Abscence of cognitive impairment (Short Portable Mental Questionnaire >7points)
- Did not fulfill any exclusion criteria
- Included into the randomized controlled trial.
- Did not give their informed consent for participation in the randomized controlled trial.
- Patients above 80 years of age excluded from participation in the randomized controlled trial due to fulfillment of exclusion criteria or did not fulfill inclusion criteria.
Who cannot join
- Patient with osteoarthritis or rheumatoid arthritis in the fractured hip
- Pathological fracture
- Non walker
- Cognitive impairment (Short Portable Mental Questionnaire <7points)
- Contraindication to total hip replacement due to wound, patients with comorbidities, deemed not suitable for a total hip replacement by the anesthesiologist, severe coagulation disorder, and severe drug abuse.
- Deemed unsuitable for inclusion by other reason.
- Age below 80 years of age.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic department, Danderyd Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: External Validity of a Randomized Controlled Trial in Patients With a Femoral Neck Fracture
The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced femoral neck fracture.
The hypotheses are that patient reported hip function, quality of life are better and healthier in those included in the randomized controlled trial than those excluded. The external validity of the randomized controlled trial is acceptable.
Read more
A prospective randomized controlled trial is planned and patients with a displaced femoral neck fracture will be included and randomized between either a hemiarthroplasty or total hip arthroplasty. All patients screened will be included in a prospective cohort study for evaluation of the external validity of the randomized controlled trial. The prospective cohort study will consist of 3 different groups.
Patients included in the randomized controlled trial will form group 1. Patients eligible for the randomized controlled trial but did not give their informed consent and therefore excluded, form group 2.
Patients with a femoral neck fracture which by any reason were excluded form group 3.
Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality of life evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of the complications, periprosthetic fracture, dislocation, revision surgery due to wound infection (deep and superficial) and loosening of the components. Baseline data, age, sex, comorbidity, cognitive status, weight, height, motor function, complications and reoperations. Follow up is performed 1-2 years after surgery.
Group 1 is followed up in the ongoing randomized controlled trial by visits to the orthopedic department at Danderyd Hospital. Group 2 and 3 are followed up by telephone interview 1-2 year after surgery.
Read the detailed description
The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced femoral neck fracture.
The hypotheses are:
- The patient reported hip function and quality of life are better in those included in the randomized controlled trial than those excluded.
- Patients included in the study are healthier than those excluded.
- The external validity of the randomized controlled trial is acceptable, defined as the difference between patients that provide and do not provide their informed consent do not reach clinical significance (a mean difference in Harris hip score of 10 points).
All patients above 80 years old with an acute displaced femoral neck fracture at Danderyds hospital AB during 2009-2016 will be screened and asked for participation in a randomized controlled trial. Those who fulfill the criteria for inclusion and give their informed consent are enrolled in the randomized controlled trial. Patients that will not give their informed consent and those which do not fulfill the inclusion criteria are enrolled in a prospective cohort study for evaluation of the external validity.
The prospective cohort study will consist of 3 different groups. Patients included in the randomized controlled trial study will form group 1. Patients eligible for the randomized controlled trial but did not give their informed consent and therefore excluded, form group 2.
Patients with a femoral neck fracture which by any reason were excluded form group 3.
Follow-up is performed 1-2 years after surgery. Inclusion criteria in the randomized controlled trial.
- Age above 80 years 2. Acute (<36h) displaced femoral neck fracture. 3. Independent walker 4. Abscence of cognitive impairment (Pfeiffer test >7) 5. Did not fulfill any exclusion criteria Exclusion criteria in the randomized controlled trial
- Patient with osteoarthritis or rheumatoid arthritis in the fractured hip
- Pathological fracture
- Non walker
- Cognitive impairment (Short Portable Mental Questionnaire <7)
- Contraindication to total hip replacement due to wound, patients with comorbidities, deemed not suitable for a total hip replacement by the anesthesiologist, severe coagulation disorder, and severe drug abuse.
- Deemed unsuitable for inclusion by other reason.
- Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated extremity evaluated with VAS (Visual Analogue Scale)
- Patient reported quality of life evaluated with EQ-5D.
Secondary outcome:
- Secondary outcome measurement are the frequency of the complications, periprosthetic fracture, dislocation, revision surgery due to wound infection (deep and superficial) and loosening of the components.
- Baseline data, age, sex, comorbidity, cognitive status, weight, height, motor function and complications and reoperations.
Secondary outcome measurements are obtained in the medical records.
- Conditions
- Femoral Neck Fracture, Hip Fracture
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Included | Patients included into the randomized controlled trial | |
| Non-consenters | Patients eligible for participation in the randomized controlled trial but did not give their informed consent and thus excluded in the randomized controlled trial. | |
| Excluded | Patients, by different reasons excluded from participation in the randomized controlled trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris hip score
Hip function as a patient reported outcome measurement
Measured: Up to 2 years
Secondary outcomes (4)
Baseline data (Preoperative baseline data obtained at admission to the hospital)
Age, sex, date of surgery, type of surgical treatment, surgical approach, time, level of competence of the treating surgeon, American Society of Anesthesiologists grade determined by treating anesthesiologist, surgical time, patients weight and length
Measured: 1 day
Mortality
Measured: up to 2 years
Complications (Any reason to reoperation)
Any reason to reoperation most commonly prosthetic dislocation, deep infection, periprosthetic dislocation
Measured: up to 4 years years
EQ-5D
Health related quality of life, patient reported outcome
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startSep 2009
- Primary completionOct 2018 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FractureStudies 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Olof G Skoldenberg, MD, PhD, Principal investigator, Department of clinical sciences at Danderyds hospital, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362971
- Sponsor's protocol ID
- External validity
- Acronym
- EXVAL
- Status last verified
- Aug 2016
- First submitted
- 26 Jan 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Evidence-based health care: a new approach to teaching the practice of health care. Evidence-Based Medicine Working Group. J Dent Educ. 1994 Aug;58(8):648-53. No abstract available.
PubMed 7930000Petersen MK, Andersen KV, Andersen NT, Soballe K. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop. 2007 Feb;78(1):12-8. doi: 10.1080/17453670610013367.
PubMed 17453387Pibouleau L, Boutron I, Reeves BC, Nizard R, Ravaud P. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review. BMJ. 2009 Nov 17;339:b4538. doi: 10.1136/bmj.b4538.
PubMed 19920015van den Bekerom MP, Hilverdink EF, Sierevelt IN, Reuling EM, Schnater JM, Bonke H, Goslings JC, van Dijk CN, Raaymakers EL. A comparison of hemiarthroplasty with total hip replacement for displaced intracapsular fracture of the femoral neck: a randomised controlled multicentre trial in patients aged 70 years and over. J Bone Joint Surg Br. 2010 Oct;92(10):1422-8. doi: 10.1302/0301-620X.92B10.24899.
PubMed 20884982Gao H, Liu Z, Xing D, Gong M. Which is the best alternative for displaced femoral neck fractures in the elderly?: A meta-analysis. Clin Orthop Relat Res. 2012 Jun;470(6):1782-91. doi: 10.1007/s11999-012-2250-6. Epub 2012 Jan 26.
PubMed 22278852Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8.
PubMed 15639683
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validity of a Randomized Controlled Trial in Patients With a Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT02362971
- Acronym / sponsor ID
- EXVAL / External validity
- Conditions
- Femoral Neck Fracture, Hip Fracture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- 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.
The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced femoral neck fracture.
The hypotheses are that patient reported hip function, quality of life are better and healthier in those included in the randomized controlled trial than those excluded. The external validity of the randomized controlled trial is acceptable.
A prospective randomized controlled trial is planned and patients with a displaced femoral neck fracture will be included and randomized between either a hemiarthroplasty or total hip arthroplasty. All patients screened will be included in a prospective cohort study for evaluation of the external validity of the randomized controlled trial. The prospective cohort study will consist of 3 different groups.
Patients included in the randomized controlled trial will form group 1. Patients eligible for the randomized controlled trial but did not give their informed consent and therefore excluded, form group 2.
Patients with a femoral neck fracture which by any reason were excluded form group 3.
Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated extremity evaluated with VAS (Visual Analogue Scale) and patient reported quality of life evaluated with EuroQol (EQ-5D). Secondary outcome measurement are the frequency of the complications, periprosthetic fracture, dislocation, revision surgery due to wound infection (deep and superficial) and loosening of the components. Baseline data, age, sex, comorbidity, cognitive status, weight, height, motor function, complications and reoperations. Follow up is performed 1-2 years after surgery.
Group 1 is followed up in the ongoing randomized controlled trial by visits to the orthopedic department at Danderyd Hospital. Group 2 and 3 are followed up by telephone interview 1-2 year after surgery.
Detailed description
The aim of this study is to evaluate the external validity of a randomized controlled trial comparing choice of hip arthroplasty for elderly patients (>80 years) with a displaced femoral neck fracture.
The hypotheses are:
- The patient reported hip function and quality of life are better in those included in the randomized controlled trial than those excluded.
- Patients included in the study are healthier than those excluded.
- The external validity of the randomized controlled trial is acceptable, defined as the difference between patients that provide and do not provide their informed consent do not reach clinical significance (a mean difference in Harris hip score of 10 points).
All patients above 80 years old with an acute displaced femoral neck fracture at Danderyds hospital AB during 2009-2016 will be screened and asked for participation in a randomized controlled trial. Those who fulfill the criteria for inclusion and give their informed consent are enrolled in the randomized controlled trial. Patients that will not give their informed consent and those which do not fulfill the inclusion criteria are enrolled in a prospective cohort study for evaluation of the external validity.
The prospective cohort study will consist of 3 different groups. Patients included in the randomized controlled trial study will form group 1. Patients eligible for the randomized controlled trial but did not give their informed consent and therefore excluded, form group 2.
Patients with a femoral neck fracture which by any reason were excluded form group 3.
Follow-up is performed 1-2 years after surgery. Inclusion criteria in the randomized controlled trial.
- Age above 80 years 2. Acute (<36h) displaced femoral neck fracture. 3. Independent walker 4. Abscence of cognitive impairment (Pfeiffer test >7) 5. Did not fulfill any exclusion criteria Exclusion criteria in the randomized controlled trial
- Patient with osteoarthritis or rheumatoid arthritis in the fractured hip
- Pathological fracture
- Non walker
- Cognitive impairment (Short Portable Mental Questionnaire <7)
- Contraindication to total hip replacement due to wound, patients with comorbidities, deemed not suitable for a total hip replacement by the anesthesiologist, severe coagulation disorder, and severe drug abuse.
- Deemed unsuitable for inclusion by other reason.
- Primary endpoint is patient-reported hip function (Harris hip score) and pain on the operated extremity evaluated with VAS (Visual Analogue Scale)
- Patient reported quality of life evaluated with EQ-5D.
Secondary outcome:
- Secondary outcome measurement are the frequency of the complications, periprosthetic fracture, dislocation, revision surgery due to wound infection (deep and superficial) and loosening of the components.
- Baseline data, age, sex, comorbidity, cognitive status, weight, height, motor function and complications and reoperations.
Secondary outcome measurements are obtained in the medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Included | – | –Patients included into the randomized controlled trial |
| Non-consenters | – | –Patients eligible for participation in the randomized controlled trial but did not give their informed consent and thus excluded in the randomized controlled trial. |
| Excluded | – | –Patients, by different reasons excluded from participation in the randomized controlled trial. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- A femoral neck fracture in the elderly patient is a common cause of suffering and premature death in an aging population. Femoral neck fractures are mainly a fragility (osteoporotic) fracture, predominantly affecting women after menopause. Included in the study are elderly patients (>80 years) with a displaced femoral neck fracture.
Key inclusion criteria (8 listed)
- Age above 80 years
- Acute (<36h) displaced femoral neck fracture.
- Independent walker
- Abscence of cognitive impairment (Short Portable Mental Questionnaire >7points)
- Did not fulfill any exclusion criteria
Key exclusion criteria (7 listed)
- Patient with osteoarthritis or rheumatoid arthritis in the fractured hip
- Pathological fracture
- Non walker
- Cognitive impairment (Short Portable Mental Questionnaire <7points)
- Contraindication to total hip replacement due to wound, patients with comorbidities, deemed not suitable for a total hip replacement by the anesthesiologist, severe coagulation disorder, and severe drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Harris hip score
Time frame: Up to 2 years
Hip function as a patient reported outcome measurement
4 secondary outcomes
Baseline data (Preoperative baseline data obtained at admission to the hospital)
Time frame: 1 day
Mortality
Time frame: up to 2 years
Complications (Any reason to reoperation)
Time frame: up to 4 years years
EQ-5D
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Background: PubMed 7930000Evidence-based health care: a new approach to teaching the practice of health care. Evidence-Based Medicine Working Group. J Dent Educ. 1994 Aug;58(8):648-53. No abstract available.
- Background: PubMed 17453387Petersen MK, Andersen KV, Andersen NT, Soballe K. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop. 2007 Feb;78(1):12-8. doi: 10.1080/17453670610013367.
- Background: PubMed 19920015Pibouleau L, Boutron I, Reeves BC, Nizard R, Ravaud P. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review. BMJ. 2009 Nov 17;339:b4538. doi: 10.1136/bmj.b4538.
- Background: PubMed 20884982van den Bekerom MP, Hilverdink EF, Sierevelt IN, Reuling EM, Schnater JM, Bonke H, Goslings JC, van Dijk CN, Raaymakers EL. A comparison of hemiarthroplasty with total hip replacement for displaced intracapsular fracture of the femoral neck: a randomised controlled multicentre trial in patients aged 70 years and over. J Bone Joint Surg Br. 2010 Oct;92(10):1422-8. doi: 10.1302/0301-620X.92B10.24899.
- Background: PubMed 22278852Gao H, Liu Z, Xing D, Gong M. Which is the best alternative for displaced femoral neck fractures in the elderly?: A meta-analysis. Clin Orthop Relat Res. 2012 Jun;470(6):1782-91. doi: 10.1007/s11999-012-2250-6. Epub 2012 Jan 26.
- Background: PubMed 15639683Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005 Jan 1-7;365(9453):82-93. doi: 10.1016/S0140-6736(04)17670-8.
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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.
Olof G Skoldenberg, MD, PhD principal investigator
Department of clinical sciences at Danderyds hospital, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture and Hip Fracture, run by Danderyd Hospital at 1 site in Sweden.
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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Harris hip score (time frame: Up to 2 years). 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 NCT02362971, which also lists 6 linked publications.
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 30 Aug 2016.