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Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures

NCT ID: NCT01408693

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-04-30

Brief Summary

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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).

Detailed Description

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HA via various well established approaches is the typical treatment for displaced femoral neck fractures in elderly patients. In the last decade, so called minimal-invasive surgery (MIS) for the implantation of total hip arthroplasty (THA) has become popular and studies have demonstrated that MIS is as safe as conventional approaches. Our hypothesis is that femoral neck fracture patients may especially benefit from MIS. To date, no published data exist comparing a Hueter minimal-invasive anterior (AMIS) with a conventional trans-gluteal Hardinge approach (CLAS) for HA.

Geriatric patients presenting at the University hospital Basel (UHBS) with a femoral neck fracture eligible for HA are randomly assigned to the minimal-invasive or conventional group. In both groups HA will be performed using the same implants. Postoperatively patients will be followed-up continuously until discharge from our hospital (with 7 days as expected average duration of postoperative hospital stay) with a first functional status assessment on day 5. Further follow-up is planned at week 3 and 6, 3 months and one year postoperatively.

Conditions

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Femoral Neck Fracture

Keywords

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hip fracture hemiarthroplasty endoprosthesis elderly minimally invasive surgery anterior approach geriatric patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anterior minimal invasive approach, AMIS

AMIS in 95 randomized patients.

Group Type ACTIVE_COMPARATOR

Anterior minimal invasive approach, AMIS

Intervention Type PROCEDURE

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

Trans-gluteal approach, CLAS

CLAS in 95 randomized patients.

Group Type ACTIVE_COMPARATOR

Trans-gluteal approach, CLAS

Intervention Type PROCEDURE

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

Interventions

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Trans-gluteal approach, CLAS

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

Intervention Type PROCEDURE

Anterior minimal invasive approach, AMIS

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

Intervention Type PROCEDURE

Other Intervention Names

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Mecacta, Mathys, Switzerland Medacta, Mathys, Switzerland

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcel Jakob, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Traumatology, University hospital Basel

Locations

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Department of Traumatology, University Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3503663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12751884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2240918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16330993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19576398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20559827 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30241509 (View on PubMed)

Other Identifiers

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UHBS-TRAUMA-68/11

Identifier Type: -

Identifier Source: org_study_id