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Femoral Neck FracturePhase 4MIS-CLASNCT01408693

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

A Phase 4 study testing Trans-gluteal approach, CLAS and Anterior minimal invasive approach, AMIS in people with Femoral Neck Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Femoral Neck Fracture
What is being tested?
Trans-gluteal approach, CLAS and Anterior minimal invasive approach, AMIS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteSwitzerland
Study dates
Aug 2011to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Traumatology, University Hospital

    Basel, 4031

Other trials in Switzerland

About this study

Official title: Minimal Invasive Anterior Approach Versus Trans-gluteal Approach for Hemi-arthroplasty in Femoral Neck Fractures - A Prospective Randomized Trial

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).

Read the detailed description

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.

Being tested
Trans-gluteal approach, CLAS, Anterior minimal invasive approach, AMIS
Keywords
hip fracture, hemiarthroplasty, endoprosthesis, elderly, minimally invasive surgery, anterior approach, geriatric patients
Medical subject headings
Femoral Neck Fractures, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans-gluteal approach, CLASProcedure or surgery

    Also called Mecacta, Mathys, Switzerland

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

  • Anterior minimal invasive approach, AMISProcedure or surgery

    Also called Medacta, Mathys, Switzerland

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

Study groups in NCT01408693
Study groupRoleWhat they receive
Anterior minimal invasive approach, AMISActive comparatorAMIS in 95 randomized patients.
Receives: Procedure: Anterior minimal invasive approach, AMIS
Trans-gluteal approach, CLASActive comparatorCLAS in 95 randomized patients.
Receives: Procedure: Trans-gluteal approach, CLAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 weeks postoperatively +/- 3 days

Secondary outcomes (8)

  1. Functional Independence measure (FIM)

    FIM is a widely used method of assessing quality of daily life and the amount of assistance required for a person with a disability to perform basic activities safely and effectively. It includes 18 items focusing on a minimum set of skills related to self-care, sphincter control, transfers, locomotion, communication, and social cognition. Possible scores range from 18 to 126.

    Measured: 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 )

  2. Postoperative complications

    Postoperative complications (proximal femoral fracture, nerve palsy, postoperative surgical site infection, aseptic loosening, peri-prosthetic fracture, re-operation, non-surgical complications etc.) as a secondary outcome variable will be continuously recorded using the Clavien-Dindo classification of surgical complications

    Measured: duration from surgery until 1 year postoperatively

  3. Peri-operative delirium

    To assess delirium, patients will be screened 3 times a day by the responsible nurse using a modified Delirium Observation Screening scale (DOS). DOS is a 13-item scale for early recognition of delirium. If DOS results in equal or more than 3 points, the Confusion Assessment Method (CAM) will be additionally applied. The CAM instrument consists of 4 respectively 5 operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).

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

  4. One year mortality

    Measured: one year

  5. Length of hospitalization

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

  6. Subgroup effect of patients with normal Mental-state Questionnaire (MSQ) versus patients with abnormal (MSQ)

    Corresponding to the results of the mental state questionnaire at the admission patients are evaluated able to judge or not able to judge. An analysis of subgroup-effect for the other outcome variables will be done.

    Measured: one year

  7. Peri-operative factors

    Blood loss (estimated by anesthesiologist and surgeon) and blood transfusion (amount) Duration of surgery (skin-incision - skin closure)

    Measured: Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days

  8. Timed up and go test (TUG)

    see primary outcome measure

    Measured: day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionApr 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01408693
Sponsor's protocol ID
UHBS-TRAUMA-68/11
Acronym
MIS-CLAS
Status last verified
Oct 2017
First submitted
10 Jun 2011
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 1991946

  • 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.

    PubMed 3503663

  • 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.

    PubMed 12751884

  • 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.

    PubMed 2240918

  • 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.

    PubMed 19638912

  • 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.

    PubMed 16330993

  • 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.

    PubMed 19576398

  • 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.

    PubMed 20559827

  • 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.

    PubMed 30241509

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trans-gluteal approach, CLAS and Anterior minimal invasive approach, AMIS in people with Femoral Neck Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed up and go test (TUG) (time frame: 3 weeks postoperatively +/- 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01408693, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.

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