Undisplaced Femoral Neck Fractures in the Elderly: A Trial Comparing Internal Fixation to Hemiarthroplasty

NCT01770769 | Unknown DMC

• 1 other identifier: NEM-2011/2296
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.

Conditions

Femoral Neck Fractures

Keywords

Femoral Neck Fracture; undisplaced; minimally displaced; internal fixation; hemiarthroplasty; harris hip score; hospital cost; society cost; quality of life; Timed Up and go test

Outcome Measures

Primary Outcomes (1)

• Change in Harris Hip Score of 10 points or more.

  Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.

  Baseline prior to fracture, 3 months, 1 year and 2 years

Secondary Outcomes (7)

• Euro-Quol 5 dimension (Eq5d)

  Baseline prior to fracture, 3 months, 1 year and 2 years

• Numeric pain intensity scale (0-10)

  Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years

• Timed Up and Go test (TUG test)

  3 months, 1 year and 2 years

• Reoperation rate

  5 years after surgery

• Death

  5 years after surgery

Study Arms (2)

Internal fixation - standard treatment

ACTIVE COMPARATOR

Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment

Device: internal fixation

Hemi - arthroplasty

EXPERIMENTAL

cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.

Device: Hemi - arthroplasty

Interventions

Hemi - arthroplasty DEVICE

modular hemiarthroplasty

Also known as: Hemiarthroplasty by Stryker - Exeter V40(R), Hemiarthroplasty by DePuy - Corail, Refobacin® Bone Cement R & Biomet, Cloxacillin or cephalothin perioperative prophylaxis, Fragmin (Dalteparin) anticoagulation for 2 wks

Hemi - arthroplasty

internal fixation DEVICE

Two cancellous parallel screws - internal fixation of the femoral neck fracture

Also known as: Hip Pins (R), Cloxacillin or cephalothin perioperative prophylaxis, Fragmin (Dalteparin) anticoagulation for 2 wks

Internal fixation - standard treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 70 years or older
• Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
• Patient able to walk before injury (all aids allowed)
• Patient lives within the catchment area of the three involved centres

You may not qualify if:

• Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
• Pathologic fracture
• Current soft tissue or deep infection in the hip or pelvis area
• ASA IV patients as classified by the anesthesiologist on call
• Other contraindications to either of the two methods compared
• Temporarily impaired cognitive function:
• (That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• Asker & Baerum Hospital: collaborator
• Sykehuset Innlandet HF: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (1)

Akershus University Hospital

Lillestrøm, N-1478, Norway

Location

Related Publications (12)

• 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

• Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD001708. doi: 10.1002/14651858.CD001708.pub2.

  PMID: 17054139 BACKGROUND

• Frihagen F, Waaler GM, Madsen JE, Nordsletten L, Aspaas S, Aas E. The cost of hemiarthroplasty compared to that of internal fixation for femoral neck fractures. 2-year results involving 222 patients based on a randomized controlled trial. Acta Orthop. 2010 Aug;81(4):446-52. doi: 10.3109/17453674.2010.492763.

  PMID: 20515432 BACKGROUND

• Heetveld MJ, Rogmark C, Frihagen F, Keating J. Internal fixation versus arthroplasty for displaced femoral neck fractures: what is the evidence? J Orthop Trauma. 2009 Jul;23(6):395-402. doi: 10.1097/BOT.0b013e318176147d.

  PMID: 19550224 BACKGROUND

• Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.

  PMID: 18056740 BACKGROUND

• Rogmark C, Carlsson A, Johnell O, Sernbo I. A prospective randomised trial of internal fixation versus arthroplasty for displaced fractures of the neck of the femur. Functional outcome for 450 patients at two years. J Bone Joint Surg Br. 2002 Mar;84(2):183-8. doi: 10.1302/0301-620x.84b2.11923.

  PMID: 11922358 BACKGROUND

• Bjorgul K, Reikeras O. Hemiarthroplasty in worst cases is better than internal fixation in best cases of displaced femoral neck fractures: a prospective study of 683 patients treated with hemiarthroplasty or internal fixation. Acta Orthop. 2006 Jun;77(3):368-74. doi: 10.1080/17453670610046271.

  PMID: 16819673 BACKGROUND

• 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.

  PMID: 19070851 BACKGROUND

• Zlowodzki M, Ayeni O, Petrisor BA, Bhandari M. Femoral neck shortening after fracture fixation with multiple cancellous screws: incidence and effect on function. J Trauma. 2008 Jan;64(1):163-9. doi: 10.1097/01.ta.0000241143.71274.63.

  PMID: 18188116 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

• Zlowodzki M, Jonsson A, Paulke R, Kregor PJ, Bhandari M. Shortening after femoral neck fracture fixation: is there a solution? Clin Orthop Relat Res. 2007 Aug;461:213-8. doi: 10.1097/BLO.0b013e31805b7ec4.

  PMID: 17415006 BACKGROUND

• Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.

  PMID: 18656868 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Hemiarthroplasty; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Fracture Fixation; Therapeutics

Study Officials

• Torbjørn Omland, Professor

  University Hospital, Akershus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: January 18, 2013
• Study Start: February 6, 2012
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

NO (1)