Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture

Femoral Neck Fractures Clinical Trial

— SENSE  

Official title:

Is arthroplaSty bEtter Than interNal Fixation in the undiSplaced Femoral nEck Fracture? A National Pragmatical Randomized Controlled Trial - the SENSE Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04075461
• Other study ID #: S-20180036
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 26, 2025

Study information

• Verified date: February 2024
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: January 26, 2025
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• The fracture is pathological
• The patient does not speak Danish

Related Conditions & MeSH terms

• Arthroplasty Complications
• Femoral Neck Fractures
• Fractures, Bone
• Internal Fixation; Complications
• Undisplaced Fracture

Intervention

Procedure:
• Arthroplasty
Arthroplasty is commonly used for a displaced femoral neck fracture.
• Internal fixation
Internal fixation is commonly used for undisplaced femoral neck fracture

Locations

Country	Name	City	State
Denmark	Hospital of Southern Jutland	Aabenraa
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Herlev Hospital	Copenhagen
Denmark	Hvidovre Hospital	Copenhagen
Denmark	Regional Hospital West Jutland	Gødstrup
Denmark	Hospital of North Zealand	Hillerød
Denmark	North Denmark Regional Hospital	Hjørring
Denmark	Holbæk Hospital	Holbæk
Denmark	Randers Regional Hospital	Horsens
Denmark	Zealand University Hospital	Køge
Denmark	Lillebaelt Hospital	Kolding
Denmark	Nykøbing Falster Hospital	Nykøbing Falster
Denmark	Odense University Hospital	Odense
Denmark	Randers Regional Hospital	Randers
Denmark	Bornholm Hospital	Rønne
Denmark	Slagelse Hospital	Slagelse
Denmark	Viborg Regional Hospital	Viborg

Sponsors (21)

Lead Sponsor

Collaborator

University of Southern Denmark

Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Bornholm Hospital, Herlev Hospital, Hillerod Hospital, Denmark, Holbaek Sygehus, Hospital of South West Jutland, Hospital of Southern Jutland, Hvidovre University Hospital, North Denmark Regional Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Randers Regional Hospital, Regional Hospital West Jutland, Regionshospitalet Horsens, Regionshospitalet Viborg, Skive, Slagelse Hospital, Sygehus Lillebaelt, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (22)

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de 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. — View Citation

Dolatowski 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. — View Citation

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. — View Citation

Kristensen 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. — View Citation

Kristensen 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. — View Citation

Kristensen MT. Hip fractures - Functional assessments and factors influencing in-hospital outcome, a physiotherapeutic perspective. Faculty of Medicine: Lund University; 2010.

Kristensen 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. — View Citation

Loudon 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. — View Citation

Lu 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. — View Citation

National Institute for Health and Care Excellence. Hip fracture: mangement. Clinical guideline [CG124]. National Institute for Health and Care Excellence; 2011, updated 2017.

Palm H, Gosvig K, Krasheninnikoff M, Jacobsen S, Gebuhr P. A new measurement for posterior tilt predicts reoperation in undisplaced femoral neck fractures: 113 consecutive patients treated by internal fixation and followed for 1 year. Acta Orthop. 2009 Jun;80(3):303-7. doi: 10.3109/17453670902967281. — View Citation

Parker 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. — View Citation

Pedersen TJ, Lauritsen JM. Routine functional assessment for hip fracture patients. Acta Orthop. 2016 Aug;87(4):374-9. doi: 10.1080/17453674.2016.1197534. Epub 2016 Jun 22. — View Citation

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. — View Citation

Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26. — View Citation

Sikand 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. — View Citation

Steihaug OM, Gjesdal CG, Bogen B, Kristoffersen MH, Lien G, Hufthammer KO, Ranhoff AH. Does sarcopenia predict change in mobility after hip fracture? a multicenter observational study with one-year follow-up. BMC Geriatr. 2018 Mar 5;18(1):65. doi: 10.1186/s12877-018-0755-x. — View Citation

The Danish Interdisciplinary Registry for Hip Fracture. National Annual Report for 2017. The Danish Healthcare Service; 2017 15.05.2017.

Wamper 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. — View Citation

Zlowodzki 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. — View Citation

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New Mobility Score (NMS)	NMS score the level of function with a score from 0-9 points. The best score is 9 points.	2 and 5 years
Other	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	2 and 5 years
Other	Reoperation	New surgery in relation to the primary surgery, given in numbers and percentage	2 and 5 years
Other	Mortality	Mortality given in number of deaths and percentage	2 and 5 years
Other	Pain Verbal Rating Scale (VRS)	Patient reported outcome of pain assessment of pain from 1 to 10	2 and 5 years
Other	Oxford Hip Score (OHS)	Specific hip function questionnaire with a score from 0-48 points. The best score is 48 points.	2 and 5 years
Other	de Morton Mobility Index (DEMMI)	Mobility index with a score from 0-100 points. The best score is 100 points	Admission, 3 months, 6 months, 12 months, 2 and 5 years
Other	Barthel-20	Index for activities of daily living with a score from 0-20 points. The best score is 20 points.	Admission, 3 months, 6 months, 12 months, 2 and 5 years
Other	Cumulated Cumulated Ambulation Score (CAS)	Basic mobility score with a score from 0-6 points. The best score is 6 points.	Admission, 6 and 12 weeks
Other	X-ray measurement 1	Quality of implant positioning (IMPO) score with a score from 0-6 point. The best score is 6 points	First postoperative x-ray during admission and 1 year
Primary	New Mobility Score (NMS)	NMS score the level of function with a score from 0-9 points. The best score is 9 points.	12 months
Secondary	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	Admission, 3 months, 6 months and 12 months.
Secondary	Oxford Hip Score (OHS)	Specific hip function questionnaire with a score from 0-48 points. The best score is 48 points.	Admission, 3 months, 6 months and 12 months.
Secondary	Reoperation	New surgery in relation to the primary surgery	Within 1 year after surgery
Secondary	Mortality	Mortality	Within 1 year after surgery
Secondary	New Mobility Score (NMS)	NMS score the level of function with a score from 0-9 points. The best score is 9 points.	Admission, 3 and 6 months
Secondary	Pain Verbal Rating Scale (VRS)	Patient reported outcome of pain assessment	Admission, 2 and 6 weeks, 3, 6, and 12 months