Undisplaced FractureSENSENCT04075461
Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture
A study testing Arthroplasty and Internal fixation in people with Undisplaced Fracture and Femoral Neck Fractures, run by University of Southern Denmark at 19 sites in Denmark.
Trial summary
This is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Undisplaced Fracture, Femoral Neck Fractures, Internal Fixation; Complications
- What is being tested?
- Arthroplasty and Internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 19 sitesDenmark
- Study dates
- 1 Feb 2020to 26 Jan 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years old
- Undisplaced femoral neck fracture
- Posterior tilt (18) less than 20 degrees
- NMS (13) = 5 and above, indicating an ability to walk
- Cognitive intact in order to achieve informed consent
Who cannot join
- The fracture is pathological
- The patient does not speak Danish
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Denmark19 sites
Hospital of Southern Jutland
Aabenraa
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Bispebjerg Hospital
Copenhagen
Herlev Hospital
Copenhagen
Hvidovre Hospital
Copenhagen
Regional Hospital West Jutland
Gødstrup
Hospital of North Zealand
Hillerød
North Denmark Regional Hospital
Hjørring
Holbæk Hospital
Holbæk
Randers Regional Hospital
Horsens
Zealand University Hospital
Køge
Lillebaelt Hospital
Kolding, 6000
Nykøbing Falster Hospital
Nykøbing Falster
Odense University Hospital
Odense
Randers Regional Hospital
Randers
Bornholm Hospital
Rønne
Slagelse Hospital
Slagelse, 4200
Viborg Regional Hospital
Viborg
About this study
Official title: Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial
This is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. The aim is to compare two surgical treatment methods (metal fixation versus artificial hip) in patients above 65 years with an undisplaced femoral neck fracture. The hypothesis is that even though an artificial hip is a larger surgical procedure than metal fixation of the broken bone, the artificial hip is more stable with less pain due the lack of a healing broken bone and therefore leads to a better and quicker mobilization after surgery. Better mobilization is one of the most important factors for decreasing mortality. We have chosen a pragmatic RCT design by using the local departmental implants. We hope that the knowledge from this study will therefore easily be implemented afterwards.
Read the detailed description
This is the world's first national orthopedic randomized controlled trial (RCT) involving 20 out of 21 departments in Denmark. The aim is to compare two surgical treatment methods (internal fixation (IF) versus arthroplasty) in patients above 65 years with an undisplaced femoral neck fracture (FNF).
Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. Undisplaced FNF is treated with internal fixation in order to aid in fracture healing. However, approximately 10% in Denmark will suffer a reoperation and two RCT's have demonstrated 20-21% reoperations. In comparison, the reoperation frequency was 5-7% for arthroplasty that also demonstrated slightly faster mobilization which is one of the most important factors for decreasing mortality. The hypothesis is therefore that even though arthroplasty is a larger surgery they benefit from the lack of fracture healing, less pain and faster mobilization.
Patients are included in the emergency department and are electronically randomized to either IF or arthroplasty before the surgery. The design is a pragmatic RCT using the implants which are available in the departments. Furthermore, the postoperative treatment protocol is "business as usual" thereby investigating the precise effect of the intervention in real clinical conditions. In addition to a great external validity this allows for easy implemented after study results. The primary outcome is a validated functional score 1 year after surgery and the sample size is calculated to 330 patients. Secondary outcome measures are additional functional assessments and questionnaires, health related quality of life and pain assessment.
We have set up a steering committee consisting of researchers and senior surgeons with a representative from each region. In addition, all but 1 hospital has a representative in project group. The project is therefore anchored in the entire Denmark.
- Conditions
- Undisplaced Fracture, Femoral Neck Fractures, Internal Fixation; Complications, Arthroplasty Complications
- Being tested
- Arthroplasty, Internal fixation
- 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.
ArthroplastyProcedure or surgery
Arthroplasty is commonly used for a displaced femoral neck fracture.
Internal fixationProcedure or surgery
Internal fixation is commonly used for undisplaced femoral neck fracture
| Study group | Role | What they receive |
|---|---|---|
| Undisplaced FNF + Arthroplasty | Experimental | Arthroplasty is the typical surgery for a displaced femoral neck fracture Receives: Procedure: Arthroplasty |
| Undisplaced FNF + Internal fixation | Active comparator | Internal fixation is the typical surgery for an undisplaced femoral neck fracture Receives: Procedure: Internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Mobility Score (NMS)
NMS score the level of function with a score from 0-9 points. The best score is 9 points.
Measured: 12 months
Secondary outcomes (6)
EuroQol 5 domain 5 level (EQ-5D-5L)
Health related quality of life assessment with a score from 0-1 point. The best score is 1 point
Measured: Admission, 3 months, 6 months and 12 months.
Oxford Hip Score (OHS)
Specific hip function questionnaire with a score from 0-48 points. The best score is 48 points.
Measured: Admission, 3 months, 6 months and 12 months.
Reoperation
New surgery in relation to the primary surgery
Measured: Within 1 year after surgery
Mortality
Mortality
Measured: Within 1 year after surgery
New Mobility Score (NMS)
NMS score the level of function with a score from 0-9 points. The best score is 9 points.
Measured: Admission, 3 and 6 months
Pain Verbal Rating Scale (VRS)
Patient reported outcome of pain assessment
Measured: Admission, 2 and 6 weeks, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Feb 2020
- Primary completion26 Jan 2024
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Undisplaced FractureStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Model description
- The study is designed as a national pragmatical RCT including all patients with an undisplaced FNF and a NMS score of 5 and above. The standard treatment in Denmark is internal fixation and the patients are randomized to arthroplasty or IF. The steering group have assessed the pragmatic attitude of the design and the study reaches 5 points in 7 of the 9 domains (Figure 1) (9). Reporting is performed accordingly to the extension of the CONSORT statements for pragmatical RCT (17). Using the PRECIS-2 we scored the study to 43 points out of 45 possible.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Regionshospital Nordjylland, Aarhus University Hospital, Odense University Hospital, Slagelse Hospital, Bispebjerg Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens, Hospital of Southern Jutland, Esbjerg Hospital - University Hospital of Southern Denmark, Hvidovre University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, Holbaek Sygehus, Zealand University Hospital, Sygehus Lillebaelt, Nykøbing Falster County Hospital, Regional Hospital West Jutland, Bornholm Hospital
- Responsible party
- Sponsor
- Investigators
- Bjarke Viberg, MD, PhD, Principal investigator, Department of Orthopaedic Surgery and Traumatology, Lillebaelt HospitalOle Brink, MD, PhD, Study chair, Department of Orthopaedic Surgery and Traumatology, Aarhus University HospitalSøren Kold, Professor, Study chair, Department of Orthopaedic Surgery and Traumatology, Aalborg University HospitalMorten S Larsen, MD, Study chair, Odense University HospitalKristoffer B Hare, MD, PhD, Study chair, Department of Orthopaedic Surgery and Traumatology, Slagelse HospitalHenrik Palm, MD, DmSc, Study chair, Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075461
- Sponsor's protocol ID
- S-20180036
- Acronym
- SENSE
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2019
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Danish regulation direct data sharing is not possible.
Publications
National Institute for Health and Care Excellence. Hip fracture: mangement. Clinical guideline [CG124]. National Institute for Health and Care Excellence; 2011, updated 2017.
Roberts KC, Brox WT, Jevsevar DS, Sevarino K. Management of hip fractures in the elderly. J Am Acad Orthop Surg. 2015 Feb;23(2):131-7. doi: 10.5435/JAAOS-D-14-00432.
PubMed 25624365Lu Q, Tang G, Zhao X, Guo S, Cai B, Li Q. Hemiarthroplasty versus internal fixation in super-aged patients with undisplaced femoral neck fractures: a 5-year follow-up of randomized controlled trial. Arch Orthop Trauma Surg. 2017 Jan;137(1):27-35. doi: 10.1007/s00402-016-2591-9. Epub 2016 Nov 11.
PubMed 27837321Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316.
PubMed 30653043Wamper KE, Sierevelt IN, Poolman RW, Bhandari M, Haverkamp D. The Harris hip score: Do ceiling effects limit its usefulness in orthopedics? Acta Orthop. 2010 Dec;81(6):703-7. doi: 10.3109/17453674.2010.537808.
PubMed 21110703Gjertsen 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 21619501Zlowodzki 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 18978271Sikand M, Wenn R, Moran CG. Mortality following surgery for undisplaced intracapsular hip fractures. Injury. 2004 Oct;35(10):1015-9. doi: 10.1016/j.injury.2004.01.004.
PubMed 15351669Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
PubMed 25956159Kristensen PK, Thillemann TM, Soballe K, Johnsen SP. Are process performance measures associated with clinical outcomes among patients with hip fractures? A population-based cohort study. Int J Qual Health Care. 2016 Dec 1;28(6):698-708. doi: 10.1093/intqhc/mzw093.
PubMed 27591269de Morton NA, Harding KE, Taylor NF, Harrison G. Validity of the de Morton Mobility Index (DEMMI) for measuring the mobility of patients with hip fracture during rehabilitation. Disabil Rehabil. 2013 Feb;35(4):325-33. doi: 10.3109/09638288.2012.705220. Epub 2012 Aug 16.
PubMed 22897700de Morton NA, Berlowitz DJ, Keating JL. A systematic review of mobility instruments and their measurement properties for older acute medical patients. Health Qual Life Outcomes. 2008 Jun 5;6:44. doi: 10.1186/1477-7525-6-44.
PubMed 18533045Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993 Sep;75(5):797-8. doi: 10.1302/0301-620X.75B5.8376443.
PubMed 8376443Kristensen MT, Foss NB, Kehlet H. [Timed Up and Go and New Mobility Score as predictors of function six months after hip fracture]. Ugeskr Laeger. 2005 Aug 29;167(35):3297-300. Danish.
PubMed 16138973Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med. 2008 Jul;40(7):589-91. doi: 10.2340/16501977-0217.
PubMed 18758678
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial
- ClinicalTrials.gov ID
- NCT04075461
- Acronym / sponsor ID
- SENSE / S-20180036
- Conditions
- Undisplaced Fracture, Femoral Neck Fractures, Internal Fixation; Complications, Arthroplasty Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Regionshospital Nordjylland, Aarhus University Hospital, Odense University Hospital, Slagelse Hospital, Bispebjerg Hospital, Regionshospitalet Viborg, Skive, Randers Regional Hospital, Regionshospitalet Horsens, Hospital of Southern Jutland, Esbjerg Hospital - University Hospital of Southern Denmark, Hvidovre University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, Holbaek Sygehus, Zealand University Hospital, Sygehus Lillebaelt, Nykøbing Falster County Hospital, Regional Hospital West Jutland, Bornholm Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 30 Aug 2019 (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 is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. The aim is to compare two surgical treatment methods (metal fixation versus artificial hip) in patients above 65 years with an undisplaced femoral neck fracture. The hypothesis is that even though an artificial hip is a larger surgical procedure than metal fixation of the broken bone, the artificial hip is more stable with less pain due the lack of a healing broken bone and therefore leads to a better and quicker mobilization after surgery. Better mobilization is one of the most important factors for decreasing mortality. We have chosen a pragmatic RCT design by using the local departmental implants. We hope that the knowledge from this study will therefore easily be implemented afterwards.
Detailed description
This is the world's first national orthopedic randomized controlled trial (RCT) involving 20 out of 21 departments in Denmark. The aim is to compare two surgical treatment methods (internal fixation (IF) versus arthroplasty) in patients above 65 years with an undisplaced femoral neck fracture (FNF).
Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. Undisplaced FNF is treated with internal fixation in order to aid in fracture healing. However, approximately 10% in Denmark will suffer a reoperation and two RCT's have demonstrated 20-21% reoperations. In comparison, the reoperation frequency was 5-7% for arthroplasty that also demonstrated slightly faster mobilization which is one of the most important factors for decreasing mortality. The hypothesis is therefore that even though arthroplasty is a larger surgery they benefit from the lack of fracture healing, less pain and faster mobilization.
Patients are included in the emergency department and are electronically randomized to either IF or arthroplasty before the surgery. The design is a pragmatic RCT using the implants which are available in the departments. Furthermore, the postoperative treatment protocol is "business as usual" thereby investigating the precise effect of the intervention in real clinical conditions. In addition to a great external validity this allows for easy implemented after study results. The primary outcome is a validated functional score 1 year after surgery and the sample size is calculated to 330 patients. Secondary outcome measures are additional functional assessments and questionnaires, health related quality of life and pain assessment.
We have set up a steering committee consisting of researchers and senior surgeons with a representative from each region. In addition, all but 1 hospital has a representative in project group. The project is therefore anchored in the entire Denmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a national pragmatical RCT including all patients with an undisplaced FNF and a NMS score of 5 and above. The standard treatment in Denmark is internal fixation and the patients are randomized to arthroplasty or IF. The steering group have assessed the pragmatic attitude of the design and the study reaches 5 points in 7 of the 9 domains (Figure 1) (9). Reporting is performed accordingly to the extension of the CONSORT statements for pragmatical RCT (17). Using the PRECIS-2 we scored the study to 43 points out of 45 possible.
| Arm | Type | Receives |
|---|---|---|
| Undisplaced FNF + Arthroplasty | Experimental | Procedure: ArthroplastyArthroplasty is the typical surgery for a displaced femoral neck fracture |
| Undisplaced FNF + Internal fixation | Active comparator | Procedure: Internal fixationInternal fixation is the typical surgery for an undisplaced femoral neck fracture |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years old
- Undisplaced femoral neck fracture
- Posterior tilt (18) less than 20 degrees
- NMS (13) = 5 and above, indicating an ability to walk
- Cognitive intact in order to achieve informed consent
Key exclusion criteria (2 listed)
- The fracture is pathological
- The patient does not speak Danish
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 |
|---|---|---|
| ArthroplastyArthroplasty is commonly used for a displaced femoral neck fracture. | Procedure or surgery | Undisplaced FNF + Arthroplasty |
| Internal fixationInternal fixation is commonly used for undisplaced femoral neck fracture | Procedure or surgery | Undisplaced FNF + Internal fixation |
Primary outcome
New Mobility Score (NMS)
Time frame: 12 months
NMS score the level of function with a score from 0-9 points. The best score is 9 points.
6 secondary outcomes
EuroQol 5 domain 5 level (EQ-5D-5L)
Time frame: Admission, 3 months, 6 months and 12 months.
Oxford Hip Score (OHS)
Time frame: Admission, 3 months, 6 months and 12 months.
Reoperation
Time frame: Within 1 year after surgery
Mortality
Time frame: Within 1 year after surgery
New Mobility Score (NMS)
Time frame: Admission, 3 and 6 months
Pain Verbal Rating Scale (VRS)
Time frame: Admission, 2 and 6 weeks, 3, 6, and 12 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 25 Mar 2025.
- BackgroundNational Institute for Health and Care Excellence. Hip fracture: mangement. Clinical guideline [CG124]. National Institute for Health and Care Excellence; 2011, updated 2017.
- Background: PubMed 25624365Roberts KC, Brox WT, Jevsevar DS, Sevarino K. Management of hip fractures in the elderly. J Am Acad Orthop Surg. 2015 Feb;23(2):131-7. doi: 10.5435/JAAOS-D-14-00432.
- Background: PubMed 27837321Lu Q, Tang G, Zhao X, Guo S, Cai B, Li Q. Hemiarthroplasty versus internal fixation in super-aged patients with undisplaced femoral neck fractures: a 5-year follow-up of randomized controlled trial. Arch Orthop Trauma Surg. 2017 Jan;137(1):27-35. doi: 10.1007/s00402-016-2591-9. Epub 2016 Nov 11.
- Background: PubMed 30653043Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316.
- Background: PubMed 21110703Wamper KE, Sierevelt IN, Poolman RW, Bhandari M, Haverkamp D. The Harris hip score: Do ceiling effects limit its usefulness in orthopedics? Acta Orthop. 2010 Dec;81(6):703-7. doi: 10.3109/17453674.2010.537808.
- 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 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 15351669Sikand M, Wenn R, Moran CG. Mortality following surgery for undisplaced intracapsular hip fractures. Injury. 2004 Oct;35(10):1015-9. doi: 10.1016/j.injury.2004.01.004.
- Background: PubMed 25956159Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
- Background: PubMed 27591269Kristensen PK, Thillemann TM, Soballe K, Johnsen SP. Are process performance measures associated with clinical outcomes among patients with hip fractures? A population-based cohort study. Int J Qual Health Care. 2016 Dec 1;28(6):698-708. doi: 10.1093/intqhc/mzw093.
- Background: PubMed 22897700de Morton NA, Harding KE, Taylor NF, Harrison G. Validity of the de Morton Mobility Index (DEMMI) for measuring the mobility of patients with hip fracture during rehabilitation. Disabil Rehabil. 2013 Feb;35(4):325-33. doi: 10.3109/09638288.2012.705220. Epub 2012 Aug 16.
- Background: PubMed 18533045de Morton NA, Berlowitz DJ, Keating JL. A systematic review of mobility instruments and their measurement properties for older acute medical patients. Health Qual Life Outcomes. 2008 Jun 5;6:44. doi: 10.1186/1477-7525-6-44.
- Individual participant dataSharing planned: No. Due to Danish regulation direct data sharing is not possible.
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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.
Bjarke Viberg, MD, PhD principal investigator
Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital
Ole Brink, MD, PhD study chair
Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital
Søren Kold, Professor study chair
Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroplasty and Internal fixation in people with Undisplaced Fracture and Femoral Neck Fractures, run by University of Southern Denmark at 19 sites in Denmark.
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 5 inclusion and 2 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Denmark. 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?
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?
New Mobility Score (NMS) (time frame: 12 months). 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 NCT04075461, which also lists 23 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 25 Mar 2025.