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

Femoral Neck Fracture Clinical Trial

— MIS-CLAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408693
• Other study ID #: UHBS-TRAUMA-68/11
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2011
• Last updated: October 23, 2017
• Start date: August 2011
• Est. completion date: April 2016

Study information

• Verified date: October 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 "Timed up and go"-test (TUG).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Trans-gluteal approach, CLAS
Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
• Anterior minimal invasive approach, AMIS
Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Locations

Country	Name	City	State
Switzerland	Department of Traumatology, University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation

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. — View Citation

Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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 )
Secondary	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	duration from surgery until 1 year postoperatively
Secondary	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).	duration from admission to day 3, an expected average period of 3-5 days
Secondary	One year mortality		one year
Secondary	Length of hospitalization		duration of the hospital stay, an expected average of 10 days
Secondary	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.	one year
Secondary	Peri-operative factors	Blood loss (estimated by anesthesiologist and surgeon) and blood transfusion (amount) Duration of surgery (skin-incision - skin closure)	Peri-operative period, i.e. time between admission until day 5 postoperative, expected average period of 5-8 days
Secondary	Timed up and go test (TUG)	see primary outcome measure	day 5, 6 weeks, 3 month and 1 year postoperatively (each +/- 3 days)