Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture (SENSE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Femoral Neck Fractures; Arthroplasty Complications; Undisplaced Fracture; Internal Fixation; Complications
• Intervention / Treatment: Procedure: Arthroplasty; Procedure: Internal fixation

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 Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bjarke Viberg, MD, PhD; Phone Number: +45 76363067; Email: bjarke.viberg@rsyd.dk
• Study Contact Backup: Name: Anne J Hansen, Secretary; Phone Number: +45 76362333; Email: anne.jess.hansen@rsyd.dk

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Hospital of Southern Jutland
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Copenhagen, Denmark
    • Bispebjerg Hospital
  • Copenhagen, Denmark
    • Herlev Hospital
  • Copenhagen, Denmark
    • Hvidovre Hospital
  • Gødstrup, Denmark
    • Regional Hospital West Jutland
  • Hillerød, Denmark
    • Hospital of North Zealand
  • Hjørring, Denmark
    • North Denmark Regional Hospital
  • Holbæk, Denmark
    • Holbæk Hospital
  • Horsens, Denmark
    • Randers Regional Hospital
  • Kolding, Denmark, 6000
    • Lillebaelt Hospital
  • Køge, Denmark
    • Zealand University Hospital
  • Nykøbing Falster, Denmark
    • Nykøbing Falster Hospital
  • Odense, Denmark
    • Odense University Hospital
  • Randers, Denmark
    • Randers Regional Hospital
  • Rønne, Denmark
    • Bornholm Hospital
  • Slagelse, Denmark, 4200
    • Slagelse Hospital
  • Viborg, Denmark
    • Viborg Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Undisplaced FNF + Arthroplasty; Arthroplasty is the typical surgery for a displaced femoral neck fracture	Procedure: Arthroplasty; Arthroplasty is commonly used for a displaced femoral neck fracture.
Active Comparator: Undisplaced FNF + Internal fixation; Internal fixation is the typical surgery for an undisplaced femoral neck fracture	Procedure: Internal fixation; Internal fixation is commonly used for undisplaced femoral neck fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Reoperation	New surgery in relation to the primary surgery	Within 1 year after surgery
Mortality	Mortality	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.	Admission, 3 and 6 months
Pain Verbal Rating Scale (VRS)	Patient reported outcome of pain assessment	Admission, 2 and 6 weeks, 3, 6, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Reoperation	New surgery in relation to the primary surgery, given in numbers and percentage	2 and 5 years
Mortality	Mortality given in number of deaths and percentage	2 and 5 years
Pain Verbal Rating Scale (VRS)	Patient reported outcome of pain assessment of pain from 1 to 10	2 and 5 years
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital; Hvidovre University Hospital; Bispebjerg Hospital; Herlev Hospital; Hillerod Hospital, Denmark; Aalborg University Hospital; Holbaek Sygehus; Regionshospitalet Viborg, Skive; Sygehus Lillebaelt; Nykøbing Falster County Hospital; Regionshospitalet Horsens; Hospital of South West Jutland; Slagelse Hospital; Regional Hospital West Jutland; Randers Regional Hospital; Hospital of Southern Jutland; North Denmark Regional Hospital; Bornholm Hospital
• Investigators: Principal Investigator: Bjarke Viberg, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital; Study Chair: Ole Brink, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital; Study Chair: Søren Kold, Professor, Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital; Study Chair: Morten S Larsen, MD, Odense University Hospital; Study Chair: Kristoffer B Hare, MD, PhD, Department of Orthopaedic Surgery and Traumatology, Slagelse Hospital; Study Chair: Henrik Palm, MD, DmSc, Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• de 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Kristensen MT. Hip fractures - Functional assessments and factors influencing in-hospital outcome, a physiotherapeutic perspective. Faculty of Medicine: Lund University; 2010.
• 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.
• The Danish Interdisciplinary Registry for Hip Fracture. National Annual Report for 2017. The Danish Healthcare Service; 2017 15.05.2017.
• Viberg B, Kold S, Brink O, Larsen MS, Hare KB, Palm H; SENSE collaborators. Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial. BMJ Open. 2020 Oct 10;10(10):e038442. doi: 10.1136/bmjopen-2020-038442.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): January 26, 2024
• Study Completion (Estimated): January 26, 2025

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: S-20180036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to Danish regulation direct data sharing is not possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No