NCT01408693

Brief Summary

The aim of the study is to test the hypothesis that patients older than 60 years with a femoral neck fracture eligible for hemi-arthroplasty (HA) operated by an anterior minimal-invasive approach as compared to a standard lateral Hardinge approach show better functional recovery postoperatively as measured by the "Timed up and go"-test (TUG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

June 10, 2011

Last Update Submit

October 23, 2017

Conditions

Femoral Neck Fracture

Keywords

hip fracturehemiarthroplastyendoprosthesiselderlyminimally invasive surgeryanterior approachgeriatric patients

Outcome Measures

Primary Outcomes (1)

  • Timed up and go test (TUG)

    TUG: Time in seconds a person needs to stand up from a chair, walk a distance of 3 meters, turn around a flag, come back and sit down again (with or without walking aids).

    3 weeks postoperatively +/- 3 days

Secondary Outcomes (8)

  • Functional Independence measure (FIM)

    preoperative (retrospective assessment), day 5 postoperatively, 3 and 6 weeks postoperatively, 3 months and 1 year postoperatively (apart from measurement on day 5 postoperative each +/- 3 days )

  • Postoperative complications

    duration from surgery until 1 year postoperatively

  • Peri-operative delirium

    duration from admission to day 3, an expected average period of 3-5 days

  • One year mortality

    one year

  • Length of hospitalization

    duration of the hospital stay, an expected average of 10 days

  • +3 more secondary outcomes

Study Arms (2)

Anterior minimal invasive approach, AMIS

ACTIVE COMPARATOR

AMIS in 95 randomized patients.

Procedure: Anterior minimal invasive approach, AMIS

Trans-gluteal approach, CLAS

ACTIVE COMPARATOR

CLAS in 95 randomized patients.

Procedure: Trans-gluteal approach, CLAS

Interventions

Trans-gluteal approach, CLASPROCEDURE

Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Also known as: Mecacta, Mathys, Switzerland
Trans-gluteal approach, CLAS
Anterior minimal invasive approach, AMISPROCEDURE

Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Also known as: Medacta, Mathys, Switzerland
Anterior minimal invasive approach, AMIS

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 60 years or more, ambulatory with/without walking aids before trauma
  • Femoral neck fracture eligible for hemi-arthroplasty in accordance with the algorithm for femoral neck fracture patients used at the University hospital Basel
  • Informed consent

You may not qualify if:

  • Refusal of consent by the patient or legal representatives to participate in the study
  • More than one fracture
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Previous surgery of the proximal femur on the same side
  • Follow-up not possible (Tourist etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Traumatology, University Hospital

Basel, 4031, Switzerland

Location

Related Publications (9)

  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND

  • Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.

    PMID: 3503663BACKGROUND

  • Schuurmans MJ, Shortridge-Baggett LM, Duursma SA. The Delirium Observation Screening Scale: a screening instrument for delirium. Res Theory Nurs Pract. 2003 Spring;17(1):31-50. doi: 10.1891/rtnp.17.1.31.53169.

    PMID: 12751884BACKGROUND

  • Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

    PMID: 2240918BACKGROUND

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912BACKGROUND

  • Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.

    PMID: 16330993BACKGROUND

  • Rachbauer F, Kain MS, Leunig M. The history of the anterior approach to the hip. Orthop Clin North Am. 2009 Jul;40(3):311-20. doi: 10.1016/j.ocl.2009.02.007.

    PMID: 19576398BACKGROUND

  • Smith TO, Blake V, Hing CB. Minimally invasive versus conventional exposure for total hip arthroplasty: a systematic review and meta-analysis of clinical and radiological outcomes. Int Orthop. 2011 Feb;35(2):173-84. doi: 10.1007/s00264-010-1075-8. Epub 2010 Jun 18.

    PMID: 20559827BACKGROUND

  • Saxer F, Studer P, Jakob M, Suhm N, Rosenthal R, Dell-Kuster S, Vach W, Bless N. Minimally invasive anterior muscle-sparing versus a transgluteal approach for hemiarthroplasty in femoral neck fractures-a prospective randomised controlled trial including 190 elderly patients. BMC Geriatr. 2018 Sep 21;18(1):222. doi: 10.1186/s12877-018-0898-9.

    PMID: 30241509DERIVED

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Marcel Jakob, Professor

    Department of Traumatology, University hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

August 3, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

CH(1)