Complications and Functional Outcome of Displaced Femoral Neck Fractures in Patients Younger Than 70 Years

NCT02085707 | Completed DMC

• 2 other identifiers: Akershus UHSophies Minde Ortopedi AS
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

Brief Summary

Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture is associated with low activity levels, hip pain and substantially reduced quality of life. Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment, and the health economic aspect a great challenge. In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck fractures treated with a total hip arthroplasty leads to a better functional outcome than osteosynthesis, and can patient-related factors be identified that predispose for femoral fracture? It is a randomized multi center study of patients operated with either total hip arthroplasty or osteosynthesis in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced femoral neck fractures.

Conditions

Femoral Neck Fractures; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Harris Hip score

  12 months

Secondary Outcomes (10)

• Harris Hip Score

  4 months and 2 years

• QoL questionnaire (EQ-5D)

  4 and 12 months, 2 years

• Hip dysfunction and Osteoarthritis Outcome Score (HOOS)

  4 and 12 months, 2 years

• VAS

  4 and 12 months, 2 years

• Complications

  4 and 12 months, 2 years

Study Arms (2)

Total hip replacement arthroplasty

ACTIVE COMPARATOR

59 off 118 patients will be randomized to total hip replacement arthroplasty

Procedure: Total hip replacement arthroplasty

Closed reduction and internal fixation

ACTIVE COMPARATOR

59 off 118 patients will be randomized to closed reduction and internal fixation. 2 cancellous parallel hip pins

Procedure: Closed reduction and internal fixation

Interventions

Total hip replacement arthroplasty PROCEDURE

treatment with total hip replacement arthroplasty with the implant chosen by the institution

Total hip replacement arthroplasty

Closed reduction and internal fixation PROCEDURE

treatment with closed reduction and internal fixation with 2 cannulated hip pins

Closed reduction and internal fixation

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with displaced femoral neck fractures Garden 3 or 4
• Age between 55 - 70 years
• Able to walk before injury

You may not qualify if:

• Refusal to participate.
• Pathological fractures for other reasons than osteoporosis.
• Senility or dementia or lack of competence to give informed consent to participate
• Fracture on the opposite side at the same time
• Expected life duration less than 12 months and American Society of Anesthesiologists (ASA) 4 + 5
• Amputated leg
• Serious neurological disease that renders THA unsuitable
• Substance narcotic abuse

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Ullevaal University Hospital: collaborator
• Haukeland University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• Lund University Hospital: collaborator

Study Sites (4)

University Hospital, Akershus

Lørenskog, Akershus, 1478, Norway

Location

Vestre Viken HF

Sandvika, Akershus, 1346, Norway

Location

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Ullevaal University Hospital

Oslo, 0450, Norway

Location

Related Publications (20)

• 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

• Johansson T, Jacobsson SA, Ivarsson I, Knutsson A, Wahlstrom O. Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthop Scand. 2000 Dec;71(6):597-602. doi: 10.1080/000164700317362235.

  PMID: 11145387 BACKGROUND

• Keating JF, Grant A, Masson M, Scott NW, Forbes JF. Randomized comparison of reduction and fixation, bipolar hemiarthroplasty, and total hip arthroplasty. Treatment of displaced intracapsular hip fractures in healthy older patients. J Bone Joint Surg Am. 2006 Feb;88(2):249-60. doi: 10.2106/JBJS.E.00215.

  PMID: 16452734 BACKGROUND

• Blomfeldt R, Tornkvist H, Ponzer S, Soderqvist A, Tidermark J. Comparison of internal fixation with total hip replacement for displaced femoral neck fractures. Randomized, controlled trial performed at four years. J Bone Joint Surg Am. 2005 Aug;87(8):1680-8. doi: 10.2106/JBJS.D.02655.

  PMID: 16085605 BACKGROUND

• Tidermark J, Ponzer S, Svensson O, Soderqvist A, Tornkvist H. Internal fixation compared with total hip replacement for displaced femoral neck fractures in the elderly. A randomised, controlled trial. J Bone Joint Surg Br. 2003 Apr;85(3):380-8. doi: 10.1302/0301-620x.85b3.13609.

  PMID: 12729114 BACKGROUND

• Bhandari M, Devereaux PJ, Tornetta P 3rd, Swiontkowski MF, Berry DJ, Haidukewych G, Schemitsch EH, Hanson BP, Koval K, Dirschl D, Leece P, Keel M, Petrisor B, Heetveld M, Guyatt GH. Operative management of displaced femoral neck fractures in elderly patients. An international survey. J Bone Joint Surg Am. 2005 Sep;87(9):2122-30. doi: 10.2106/JBJS.E.00535.

  PMID: 16140828 BACKGROUND

• Bhandari M, Devereaux PJ, Swiontkowski MF, Tornetta P 3rd, Obremskey W, Koval KJ, Nork S, Sprague S, Schemitsch EH, Guyatt GH. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003 Sep;85(9):1673-81. doi: 10.2106/00004623-200309000-00004.

  PMID: 12954824 BACKGROUND

• Masson M, Parker MJ, Fleischer S. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2003;(2):CD001708. doi: 10.1002/14651858.CD001708.

  PMID: 12804413 BACKGROUND

• Lu-Yao GL, Keller RB, Littenberg B, Wennberg JE. Outcomes after displaced fractures of the femoral neck. A meta-analysis of one hundred and six published reports. J Bone Joint Surg Am. 1994 Jan;76(1):15-25. doi: 10.2106/00004623-199401000-00003.

  PMID: 8288658 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

• McKinley JC, Robinson CM. Treatment of displaced intracapsular hip fractures with total hip arthroplasty: comparison of primary arthroplasty with early salvage arthroplasty after failed internal fixation. J Bone Joint Surg Am. 2002 Nov;84(11):2010-5. doi: 10.2106/00004623-200211000-00016.

  PMID: 12429763 BACKGROUND

• Frihagen F, Madsen JE, Aksnes E, Bakken HN, Maehlum T, Walloe A, Nordsletten L. Comparison of re-operation rates following primary and secondary hemiarthroplasty of the hip. Injury. 2007 Jul;38(7):815-9. doi: 10.1016/j.injury.2006.09.020. Epub 2006 Dec 4.

  PMID: 17145058 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

• Rogmark C, Johnell O. Orthopaedic treatment of displaced femoral neck fractures in elderly patients. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1143-9. doi: 10.1080/09638280500055933.

  PMID: 16278183 BACKGROUND

• Parker MJ, Handoll HH. Replacement arthroplasty versus internal fixation for extracapsular hip fractures. Cochrane Database Syst Rev. 2000;(2):CD000086. doi: 10.1002/14651858.CD000086.

  PMID: 10796293 BACKGROUND

• Gjertsen JE, Engesaeter LB, Furnes O, Havelin LI, Steindal K, Vinje T, Fevang JM. The Norwegian Hip Fracture Register: experiences after the first 2 years and 15,576 reported operations. Acta Orthop. 2008 Oct;79(5):583-93. doi: 10.1080/17453670810016588.

  PMID: 18839363 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

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

  PMID: 3558716 BACKGROUND

• Hoelsbrekken SE, Opsahl JH, Stiris M, Paulsrud O, Stromsoe K. Failed internal fixation of femoral neck fractures. Tidsskr Nor Laegeforen. 2012 Jun 12;132(11):1343-7. doi: 10.4045/tidsskr.11.0715. English, Norwegian.

  PMID: 22717859 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures; Osteoporosis

Interventions

Arthroplasty, Replacement, Hip; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Senior Consultant

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 13, 2014
• Study Start: January 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)