Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture

NCT04075461 | Completed DMC

• 1 other identifier: S-20180036
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Undisplaced Fracture; Femoral Neck Fractures; Internal Fixation; Complications; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• EuroQol 5 domain 5 level (EQ-5D-5L)

  Admission, 3 months, 6 months and 12 months.

• Oxford Hip Score (OHS)

  Admission, 3 months, 6 months and 12 months.

• Reoperation

  Within 1 year after surgery

• Mortality

  Within 1 year after surgery

• New Mobility Score (NMS)

  Admission, 3 and 6 months

Other Outcomes (10)

• New Mobility Score (NMS)

  2 and 5 years

• EuroQol 5 domain 5 level (EQ-5D-5L)

  2 and 5 years

• Reoperation

  2 and 5 years

Study Arms (2)

Undisplaced FNF + Arthroplasty

EXPERIMENTAL

Arthroplasty is the typical surgery for a displaced femoral neck fracture

Procedure: Arthroplasty

Undisplaced FNF + Internal fixation

ACTIVE COMPARATOR

Internal fixation is the typical surgery for an undisplaced femoral neck fracture

Procedure: Internal fixation

Interventions

Arthroplasty PROCEDURE

Arthroplasty is commonly used for a displaced femoral neck fracture.

Undisplaced FNF + Arthroplasty

Internal fixation PROCEDURE

Internal fixation is commonly used for undisplaced femoral neck fracture

Undisplaced FNF + Internal fixation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aalborg University Hospital: collaborator
• Regionshospital Nordjylland: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Slagelse Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• Randers Regional Hospital: collaborator
• Regionshospitalet Horsens: collaborator
• Hospital of Southern Jutland: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Hvidovre University Hospital: collaborator
• Herlev Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator
• Holbaek Sygehus: collaborator
• Zealand University Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• Nykøbing Falster County Hospital: collaborator
• Regional Hospital West Jutland: collaborator
• Bornholm Hospital: collaborator

Study Sites (19)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Herlev Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Regional Hospital West Jutland

Gødstrup, Denmark

Location

Hospital of North Zealand

Hillerød, Denmark

Location

North Denmark Regional Hospital

Hjørring, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

Randers Regional Hospital

Horsens, Denmark

Location

Lillebaelt Hospital

Kolding, 6000, Denmark

Location

Zealand University Hospital

Køge, Denmark

Location

Nykøbing Falster Hospital

Nykøbing Falster, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Randers Regional Hospital

Randers, Denmark

Location

Bornholm Hospital

Rønne, Denmark

Location

Slagelse Hospital

Slagelse, 4200, Denmark

Location

Viborg Regional Hospital

Viborg, Denmark

Location

Related Publications (23)

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

  BACKGROUND

• 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.

  PMID: 25624365 BACKGROUND

• 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.

  PMID: 27837321 BACKGROUND

• 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.

  PMID: 30653043 BACKGROUND

• 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.

  PMID: 21110703 BACKGROUND

• 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.

  PMID: 21619501 BACKGROUND

• 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.

  PMID: 18978271 BACKGROUND

• 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.

  PMID: 15351669 BACKGROUND

• 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.

  PMID: 25956159 BACKGROUND

• 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.

  PMID: 27591269 BACKGROUND

• 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.

  PMID: 22897700 BACKGROUND

• 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.

  PMID: 18533045 BACKGROUND

• 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.

  PMID: 8376443 BACKGROUND

• 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.

  PMID: 16138973 BACKGROUND

• 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.

  PMID: 18758678 BACKGROUND

• 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.

  PMID: 27329799 BACKGROUND

• 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.

  PMID: 19001484 BACKGROUND

• 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.

  PMID: 19634021 BACKGROUND

• 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.

  PMID: 24965263 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29506481 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33040011 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Arthroplasty; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Fracture Fixation; Therapeutics

Study Officials

• Bjarke Viberg, MD, PhD

  Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The surgeon, theater staff and patient cannot be blinded due to the nature of two very different types of surgery. However, the assessors will be blinded for type of surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 30, 2019
• Study Start: February 1, 2020
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (19)