Hip FracturesUNFNFNCT03392285
Undisplaced Femoral Neck Fractures
An observational study of Hip Fractures and Femoral Neck Fractures, run by Sundsvall Hospital.
Trial summary
Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures, Undisplaced Fracture
- What is being tested?
- Internal fixation or hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 235 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2017
- 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 65 years and older
- All sexes
- Older adult
Study population: To evaluate the potential benefit of surgery with arthroplasty. All patients treated at Sundsvall hospital, Sweden for a displaced femoral neck fracture treated with hip arthroplasty or a undisplaced femoral neck fracture treated with internal fixation were included in a prospective cohort study.
Who may be able to join
- Above 65 years old Displaced femoral neck fracture treated with hip arthroplasty Undisplaced femoral neck fracture treated with internal fixation
Who cannot join
- Pathologic fracture
About this study
Official title: Undisplaced Femoral Neck Fractures: Treatment With Internal Fixation or Hip Arthroplasty
Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty.
Methods In a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. Risk of reoperation and patient reported hip function assessed with Harris hip score and WOMAC were used as outcome measurements.
- Conditions
- Hip Fractures, Femoral Neck Fractures, Undisplaced Fracture, Internal Fixation; Complications, Arthroplasty Complications
- Being tested
- Internal fixation or hip arthroplasty
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal fixation or hip arthroplastyDevice
Patients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture.
| Study group | Role | What they receive |
|---|---|---|
| Internal fixation | Patients above 65years old with an undisplaced femoral neck fractures treated with primary internal fixation with screws. Receives: Device: Internal fixation or hip arthroplasty | |
| Hip arthroplasty | Patients above 65years old with a displaced femoral neck fractures treated with primary hip arthroplasty. Receives: Device: Internal fixation or hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Reapportions are recorded and compared between the groups.
Measured: 4 years
Secondary outcomes (3)
Harris hip score
Patient reported outcome (0-100 points) for evaluation of hip function.
Measured: 1 year postoperatively
WOMAC
Patient reported outcome (0-96 points) for evaluation of hip function.
Measured: 1 year postoperatively
Pain in the operated hip
Estimated with pain numeric rating scale (PNRS). Grading 0-10.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Jan 2013
- Primary completion31 May 2015
- Study completion31 Dec 2017
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 Hip 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392285
- Sponsor's protocol ID
- UFNF_IFvsHA
- Acronym
- UNFNF
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If researchers requests data - anonymous data will be shared.
Publications
Rogmark 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 19070851Gjertsen JE, Dybvik E, Furnes O, Fevang JM, Havelin LI, Matre K, Engesaeter LB. Improved outcome after hip fracture surgery in Norway. Acta Orthop. 2017 Oct;88(5):505-511. doi: 10.1080/17453674.2017.1344456. Epub 2017 Jul 6.
PubMed 28681677Han SK, Song HS, Kim R, Kang SH. Clinical results of treatment of garden type 1 and 2 femoral neck fractures in patients over 70-year old. Eur J Trauma Emerg Surg. 2016 Apr;42(2):191-6. doi: 10.1007/s00068-015-0528-6. Epub 2015 Apr 18.
PubMed 26038046Chen WC, Yu SW, Tseng IC, Su JY, Tu YK, Chen WJ. Treatment of undisplaced femoral neck fractures in the elderly. J Trauma. 2005 May;58(5):1035-9; discussion 1039. doi: 10.1097/01.ta.0000169292.83048.17.
PubMed 15920421Gjertsen 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 21619501Mukka S, Sjoholm P, Aziz A, Eisler T, Kadum B, Krupic F, Morberg P, Sayed-Noor A. A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial. Pilot Feasibility Stud. 2020 Jul 11;6:98. doi: 10.1186/s40814-020-00642-w. eCollection 2020.
PubMed 32670600
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undisplaced Femoral Neck Fractures: Treatment With Internal Fixation or Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03392285
- Acronym / sponsor ID
- UNFNF / UFNF_IFvsHA
- Conditions
- Hip Fractures, Femoral Neck Fractures, Undisplaced Fracture, Internal Fixation; Complications, Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 May 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Jan 2018 (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.
Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty.
Methods In a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. Risk of reoperation and patient reported hip function assessed with Harris hip score and WOMAC were used as outcome measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal fixation | – | Device: Internal fixation or hip arthroplastyPatients above 65years old with an undisplaced femoral neck fractures treated with primary internal fixation with screws. |
| Hip arthroplasty | – | Device: Internal fixation or hip arthroplastyPatients above 65years old with a displaced femoral neck fractures treated with primary hip arthroplasty. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- To evaluate the potential benefit of surgery with arthroplasty. All patients treated at Sundsvall hospital, Sweden for a displaced femoral neck fracture treated with hip arthroplasty or a undisplaced femoral neck fracture treated with internal fixation were included in a prospective cohort study.
Key inclusion criteria (1 listed)
- Above 65 years old Displaced femoral neck fracture treated with hip arthroplasty Undisplaced femoral neck fracture treated with internal fixation
Key exclusion criteria (1 listed)
- Pathologic fracture
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 |
|---|---|---|
| Internal fixation or hip arthroplastyPatients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture. | Device | Hip arthroplasty, Internal fixation |
Primary outcome
Reoperation
Time frame: 4 years
Reapportions are recorded and compared between the groups.
3 secondary outcomes
Harris hip score
Time frame: 1 year postoperatively
WOMAC
Time frame: 1 year postoperatively
Pain in the operated hip
Time frame: 1 year postoperatively
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 5 Jan 2018.
- 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 28681677Gjertsen JE, Dybvik E, Furnes O, Fevang JM, Havelin LI, Matre K, Engesaeter LB. Improved outcome after hip fracture surgery in Norway. Acta Orthop. 2017 Oct;88(5):505-511. doi: 10.1080/17453674.2017.1344456. Epub 2017 Jul 6.
- Background: PubMed 26038046Han SK, Song HS, Kim R, Kang SH. Clinical results of treatment of garden type 1 and 2 femoral neck fractures in patients over 70-year old. Eur J Trauma Emerg Surg. 2016 Apr;42(2):191-6. doi: 10.1007/s00068-015-0528-6. Epub 2015 Apr 18.
- Background: PubMed 15920421Chen WC, Yu SW, Tseng IC, Su JY, Tu YK, Chen WJ. Treatment of undisplaced femoral neck fractures in the elderly. J Trauma. 2005 May;58(5):1035-9; discussion 1039. doi: 10.1097/01.ta.0000169292.83048.17.
- 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.
- Derived from this study: PubMed 32670600Mukka S, Sjoholm P, Aziz A, Eisler T, Kadum B, Krupic F, Morberg P, Sayed-Noor A. A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial. Pilot Feasibility Stud. 2020 Jul 11;6:98. doi: 10.1186/s40814-020-00642-w. eCollection 2020.
- Individual participant dataSharing planned: No. If researchers requests data - anonymous data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Femoral Neck Fractures, run by Sundsvall Hospital.
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 1 inclusion and 1 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 5 Jan 2018. 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?
Reoperation (time frame: 4 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 NCT03392285, 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 5 Jan 2018.