Femoral Neck FracturesNCT01770769
Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty
A study testing Hemi - arthroplasty and internal fixation in people with Femoral Neck Fractures, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Hemi - arthroplasty and internal fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- 6 Feb 2012to 6 Feb 2020
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70 years or older
- Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
- Patient able to walk before injury (all aids allowed)
- Patient lives within the catchment area of the three involved centres
Who cannot join
- Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
- Pathologic fracture
- Current soft tissue or deep infection in the hip or pelvis area
- ASA IV patients as classified by the anesthesiologist on call
- Other contraindications to either of the two methods compared
- Temporarily impaired cognitive function:
- (That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty
Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.
Read the detailed description
The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The mortality rate approximates 25% during the first year after this injury. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros.
In spite of relatively well-documented treatment protocols, there is still a need for prospective randomised controlled trials to determine the optimal treatment of certain sub-groups of patients presenting with a femoral neck fracture.
Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.
According to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. Zlowodzki et al showed, by means of validated assessment scores, that patients with internally fixated undisplaced femoral neck fractures often experience shortening of the injured limb. Then again, this is associated with lower functional and life quality scores. In Rogmark´s series of patients with undisplaced femoral neck fractures treated with internal fixation, 25% patients report daily pain from the affected hip upon walking, one and a half year after surgery. Gjertsen et al analysed data for the Norwegian hip fracture registry from more than 4000 patients to demonstrate that treatment with hemiarthroplasty, due to a displaced femoral neck fracture, is associated with better function and less pain than treatment with internal fixation due to an undisplaced femoral neck fracture.
Thus, our research group will conduct a prospective randomised controlled trial to identify any differences in clinical outcome after surgical treatment of undisplaced femoral neck fractures in patients aged 70 years and older. The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. The primary outcome measure is a difference of at least 10 points in Harris Hip Score (95% power, standard deviation approximates 15 points from previous Norwegian patient series). The primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. It is important to include the cognitively impaired patients as they account for 20-25% of the study population. Patients who cannot provide informed consent due to impaired cognitive function, are included if consent is provided by a family member or relative.
- Conditions
- Femoral Neck Fractures
- Being tested
- Hemi - arthroplasty, internal fixation
- Keywords
- Femoral Neck Fracture, undisplaced, minimally displaced, internal fixation, hemiarthroplasty, harris hip score, hospital cost, society cost, quality of life, Timed Up and go test
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemi - arthroplastyDevice
Also called Hemiarthroplasty by Stryker - Exeter V40(R), Hemiarthroplasty by DePuy - Corail, Refobacin® Bone Cement R & Biomet, Cloxacillin or cephalothin perioperative prophylaxis
modular hemiarthroplasty
internal fixationDevice
Also called Hip Pins (R), Cloxacillin or cephalothin perioperative prophylaxis, Fragmin (Dalteparin) anticoagulation for 2 wks
Two cancellous parallel screws - internal fixation of the femoral neck fracture
| Study group | Role | What they receive |
|---|---|---|
| Internal fixation - standard treatment | Active comparator | Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment Receives: Device: internal fixation |
| Hemi - arthroplasty | Experimental | cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement. Receives: Device: Hemi - arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Harris Hip Score of 10 points or more.
Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.
Measured: Baseline prior to fracture, 3 months, 1 year and 2 years
Secondary outcomes (7)
Euro-Quol 5 dimension (Eq5d)
Eq5D a validated measure of quality of life and to be utilised in health economic models comparing hospital and society costs of the two surgical methods compared. The investigator is blinded.
Measured: Baseline prior to fracture, 3 months, 1 year and 2 years
Numeric pain intensity scale (0-10)
Visual analog scale variant with numbers from ranging from zero (no pain) to ten (worst possible pain). The investigator is blinded.
Measured: Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years
Timed Up and Go test (TUG test)
Patient sits on a chair, rises, walks 3 meters passing a mark, turns around, walks back and sits down. The time is recorded in seconds. The investigator is blinded.
Measured: 3 months, 1 year and 2 years
Reoperation rate
All complications are continually recorded in both trial arms.
Measured: 5 years after surgery
Death
All deaths are recorded
Measured: 5 years after surgery
Mini mental state(MMSE-NR)
Mini mental state is recorded only at 3 months follow-up
Measured: 3 months
Hospital and society costs
Use of governmental and private health care services and assistance by family members and relatives are all recorded. Validated health economical models are used to calculate the costs.
Measured: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study start6 Feb 2012
- Primary completion6 Feb 2020 (estimated)
- Study completion6 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Asker & Baerum Hospital, Sykehuset Innlandet HF, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Filip C Dolatowski, University Hospital, Akershus
- Investigators
- Torbjørn Omland, Professor, Study chair, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770769
- Sponsor's protocol ID
- NEM-2011/2296
- Status last verified
- Nov 2017
- First submitted
- 25 Apr 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data planned published in English in a peer-reviewed medical journal
Publications
Gjertsen JE, Fevang JM, Matre K, Vinje T, Engesaeter LB. Clinical outcome after undisplaced femoral neck fractures. Acta Orthop. 2011 Jun;82(3):268-74. doi: 10.3109/17453674.2011.588857.
PubMed 21619501Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD001708. doi: 10.1002/14651858.CD001708.pub2.
PubMed 17054139Frihagen F, Waaler GM, Madsen JE, Nordsletten L, Aspaas S, Aas E. The cost of hemiarthroplasty compared to that of internal fixation for femoral neck fractures. 2-year results involving 222 patients based on a randomized controlled trial. Acta Orthop. 2010 Aug;81(4):446-52. doi: 10.3109/17453674.2010.492763.
PubMed 20515432Heetveld MJ, Rogmark C, Frihagen F, Keating J. Internal fixation versus arthroplasty for displaced femoral neck fractures: what is the evidence? J Orthop Trauma. 2009 Jul;23(6):395-402. doi: 10.1097/BOT.0b013e318176147d.
PubMed 19550224Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
PubMed 18056740Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002 Mar;84(2):183-8. doi: 10.1302/0301-620x.84b2.11923.
PubMed 11922358Bjorgul K, Reikeras O. Hemiarthroplasty in worst cases is better than internal fixation in best cases of displaced femoral neck fractures: a prospective study of 683 patients treated with hemiarthroplasty or internal fixation. Acta Orthop. 2006 Jun;77(3):368-74. doi: 10.1080/17453670610046271.
PubMed 16819673Rogmark C, Flensburg L, Fredin H. Undisplaced femoral neck fractures--no problems? A consecutive study of 224 patients treated with internal fixation. Injury. 2009 Mar;40(3):274-6. doi: 10.1016/j.injury.2008.05.023. Epub 2008 Dec 13.
PubMed 19070851Zlowodzki M, Ayeni O, Petrisor BA, Bhandari M. Femoral neck shortening after fracture fixation with multiple cancellous screws: incidence and effect on function. J Trauma. 2008 Jan;64(1):163-9. doi: 10.1097/01.ta.0000241143.71274.63.
PubMed 18188116Zlowodzki M, Brink O, Switzer J, Wingerter S, Woodall J Jr, Petrisor BA, Kregor PJ, Bruinsma DR, Bhandari M. The effect of shortening and varus collapse of the femoral neck on function after fixation of intracapsular fracture of the hip: a multi-centre cohort study. J Bone Joint Surg Br. 2008 Nov;90(11):1487-94. doi: 10.1302/0301-620X.90B11.20582.
PubMed 18978271Zlowodzki M, Jonsson A, Paulke R, Kregor PJ, Bhandari M. Shortening after femoral neck fracture fixation: is there a solution? Clin Orthop Relat Res. 2007 Aug;461:213-8. doi: 10.1097/BLO.0b013e31805b7ec4.
PubMed 17415006Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.
PubMed 18656868
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty
- ClinicalTrials.gov ID
- NCT01770769
- Acronym / sponsor ID
- NEM-2011/2296
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral Neck Fracture, undisplaced, minimally displaced, internal fixation, hemiarthroplasty, harris hip score, hospital cost, society cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, Asker & Baerum Hospital, Sykehuset Innlandet HF, Vestre Viken Hospital Trust
- Study start
- 6 Feb 2012 (actual)
- Primary completion
- 6 Feb 2020 (estimated)
- Study completion
- 6 Feb 2020 (estimated)
- First posted
- 18 Jan 2013 (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.
Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.
Detailed description
The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The mortality rate approximates 25% during the first year after this injury. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros.
In spite of relatively well-documented treatment protocols, there is still a need for prospective randomised controlled trials to determine the optimal treatment of certain sub-groups of patients presenting with a femoral neck fracture.
Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.
According to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. Zlowodzki et al showed, by means of validated assessment scores, that patients with internally fixated undisplaced femoral neck fractures often experience shortening of the injured limb. Then again, this is associated with lower functional and life quality scores. In Rogmark´s series of patients with undisplaced femoral neck fractures treated with internal fixation, 25% patients report daily pain from the affected hip upon walking, one and a half year after surgery. Gjertsen et al analysed data for the Norwegian hip fracture registry from more than 4000 patients to demonstrate that treatment with hemiarthroplasty, due to a displaced femoral neck fracture, is associated with better function and less pain than treatment with internal fixation due to an undisplaced femoral neck fracture.
Thus, our research group will conduct a prospective randomised controlled trial to identify any differences in clinical outcome after surgical treatment of undisplaced femoral neck fractures in patients aged 70 years and older. The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. The primary outcome measure is a difference of at least 10 points in Harris Hip Score (95% power, standard deviation approximates 15 points from previous Norwegian patient series). The primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. It is important to include the cognitively impaired patients as they account for 20-25% of the study population. Patients who cannot provide informed consent due to impaired cognitive function, are included if consent is provided by a family member or relative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal fixation - standard treatment | Active comparator | Device: internal fixationInternal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment |
| Hemi - arthroplasty | Experimental | Device: Hemi - arthroplastycemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 70 years or older
- Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
- Patient able to walk before injury (all aids allowed)
- Patient lives within the catchment area of the three involved centres
Key exclusion criteria (7 listed)
- Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
- Pathologic fracture
- Current soft tissue or deep infection in the hip or pelvis area
- ASA IV patients as classified by the anesthesiologist on call
- Other contraindications to either of the two methods compared
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 |
|---|---|---|
| Hemi - arthroplastyAlso: Hemiarthroplasty by Stryker - Exeter V40(R), Hemiarthroplasty by DePuy - Corail, Refobacin® Bone Cement R & Biomet, Cloxacillin or cephalothin perioperative prophylaxismodular hemiarthroplasty | Device | Hemi - arthroplasty |
| internal fixationAlso: Hip Pins (R), Cloxacillin or cephalothin perioperative prophylaxis, Fragmin (Dalteparin) anticoagulation for 2 wksTwo cancellous parallel screws - internal fixation of the femoral neck fracture | Device | Internal fixation - standard treatment |
Primary outcome
Change in Harris Hip Score of 10 points or more.
Time frame: Baseline prior to fracture, 3 months, 1 year and 2 years
Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.
7 secondary outcomes
Euro-Quol 5 dimension (Eq5d)
Time frame: Baseline prior to fracture, 3 months, 1 year and 2 years
Numeric pain intensity scale (0-10)
Time frame: Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years
Timed Up and Go test (TUG test)
Time frame: 3 months, 1 year and 2 years
Reoperation rate
Time frame: 5 years after surgery
Death
Time frame: 5 years after surgery
Mini mental state(MMSE-NR)
Time frame: 3 months
Hospital and society costs
Time frame: at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 21619501Gjertsen JE, Fevang JM, Matre K, Vinje T, Engesaeter LB. Clinical outcome after undisplaced femoral neck fractures. Acta Orthop. 2011 Jun;82(3):268-74. doi: 10.3109/17453674.2011.588857.
- Background: PubMed 17054139Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD001708. doi: 10.1002/14651858.CD001708.pub2.
- Background: PubMed 20515432Frihagen F, Waaler GM, Madsen JE, Nordsletten L, Aspaas S, Aas E. The cost of hemiarthroplasty compared to that of internal fixation for femoral neck fractures. 2-year results involving 222 patients based on a randomized controlled trial. Acta Orthop. 2010 Aug;81(4):446-52. doi: 10.3109/17453674.2010.492763.
- Background: PubMed 19550224Heetveld MJ, Rogmark C, Frihagen F, Keating J. Internal fixation versus arthroplasty for displaced femoral neck fractures: what is the evidence? J Orthop Trauma. 2009 Jul;23(6):395-402. doi: 10.1097/BOT.0b013e318176147d.
- Background: PubMed 18056740Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
- Background: PubMed 11922358Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002 Mar;84(2):183-8. doi: 10.1302/0301-620x.84b2.11923.
- Background: PubMed 16819673Bjorgul K, Reikeras O. Hemiarthroplasty in worst cases is better than internal fixation in best cases of displaced femoral neck fractures: a prospective study of 683 patients treated with hemiarthroplasty or internal fixation. Acta Orthop. 2006 Jun;77(3):368-74. doi: 10.1080/17453670610046271.
- Background: PubMed 19070851Rogmark C, Flensburg L, Fredin H. Undisplaced femoral neck fractures--no problems? A consecutive study of 224 patients treated with internal fixation. Injury. 2009 Mar;40(3):274-6. doi: 10.1016/j.injury.2008.05.023. Epub 2008 Dec 13.
- Background: PubMed 18188116Zlowodzki M, Ayeni O, Petrisor BA, Bhandari M. Femoral neck shortening after fracture fixation with multiple cancellous screws: incidence and effect on function. J Trauma. 2008 Jan;64(1):163-9. doi: 10.1097/01.ta.0000241143.71274.63.
- Background: PubMed 18978271Zlowodzki M, Brink O, Switzer J, Wingerter S, Woodall J Jr, Petrisor BA, Kregor PJ, Bruinsma DR, Bhandari M. The effect of shortening and varus collapse of the femoral neck on function after fixation of intracapsular fracture of the hip: a multi-centre cohort study. J Bone Joint Surg Br. 2008 Nov;90(11):1487-94. doi: 10.1302/0301-620X.90B11.20582.
- Background: PubMed 17415006Zlowodzki M, Jonsson A, Paulke R, Kregor PJ, Bhandari M. Shortening after femoral neck fracture fixation: is there a solution? Clin Orthop Relat Res. 2007 Aug;461:213-8. doi: 10.1097/BLO.0b013e31805b7ec4.
- Background: PubMed 18656868Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.
- Individual participant dataSharing planned: Undecided. Data planned published in English in a peer-reviewed medical journal
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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.
Torbjørn Omland, Professor study chair
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemi - arthroplasty and internal fixation in people with Femoral Neck Fractures, run by University Hospital, Akershus at 1 site in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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 Norway. 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?
Results are not available in the source record.
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?
Change in Harris Hip Score of 10 points or more. (time frame: Baseline prior to fracture, 3 months, 1 year and 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 NCT01770769, which also lists 12 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 6 Nov 2017.