Minimally invasive anterior muscle-sparing versus a transgluteal approach for hemiarthroplasty in femoral neck fractures-a prospective randomised controlled trial including 190 elderly patients
- PMID: 30241509
- PMCID: PMC6151034
- DOI: 10.1186/s12877-018-0898-9
Minimally invasive anterior muscle-sparing versus a transgluteal approach for hemiarthroplasty in femoral neck fractures-a prospective randomised controlled trial including 190 elderly patients
Abstract
Background: The relevance of femoral neck fractures (FNFs) increases with the ageing of numerous societies, injury-related decline is observed in many patients. Treatment strategies have evolved towards primary joint replacement, but the impact of different approaches remains a matter of debate. The aim of this trial was to evaluate the benefit of an anterior minimally-invasive (AMIS) compared to a lateral Hardinge (LAT) approach for hemiarthroplasty in these oftentimes frail patients.
Methods: Four hundred thirty-nine patients were screened during the 44-months trial, aiming at the evaluation of 150 patients > 60 yrs. of age. Eligible patients were randomised using an online-tool with completely random assignment. As primary endpoint, early mobility, a predictor for long-term outcomes, was evaluated at 3 weeks via the "Timed up and go" test (TUG). Secondary endpoints included the Functional Independence Measure (FIM), pain, complications, one-year mobility and mortality.
Results: A total of 190 patients were randomised; both groups were comparable at baseline, with a predominance for frailty-associated factors in the AMIS-group. At 3 weeks, 146 patients were assessed for the primary outcome. There was a reduction in the median duration of TUG performance of 21.5% (CI [- 41.2,4.7], p = 0.104) in the AMIS-arm (i.e., improved mobility). This reduction was more pronounced in patients with signs of frailty or cognitive impairment. FIM scores increased on average by 6.7 points (CI [0.5-12.8], p = 0.037), pain measured on a 10-point visual analogue scale decreased on average by 0.7 points (CI: [- 1.4,0.0], p = 0.064). The requirement for blood transfusion was lower in the AMIS- group, the rate of complications comparable, with a higher rate of soft tissue complications in the LAT-group. The mortality was higher in the AMIS-group.
Conclusion: These results, similar to previous reports, support the concept that in elderly patients at risk of frailty, the AMIS approach for hemiarthroplasty can be beneficial, since early mobilisation and pain reduction potentially reduce deconditioning, morbidity and loss of independence. The results are, however, influenced by a plethora of factors. Only improvements in every aspect of the therapeutic chain can lead to optimisation of treatment and improve outcomes in this growing patient population.
Trial registration: www.clinicaltrials.gov : NCT01408693 (registered August 3rd 2011).
Keywords: Femoral neck fracture; Fracture hemiarthroplasty; Gerontotraumatology; Minimal invasive hemiarthroplasty; Orthogeriatrics; Randomized controlled trial in the elderly; Trauma surgery in geriatric patients.
Conflict of interest statement
Ethics approval and consent to participate
The trial was approved by the ethics committee (Ethikkommission beider Basel, EKBB Reference No. 68/11). Since 2014 the ethics committee incorporates several cantons under the name Ethikkommission Nordweistschweiz (EKNZ). The trial followed good clinical practice (GCP) as well as the tenets of the Declaration of Helsinki. Key personnel had appropriate training in GCP. The trial has been registered with
Eligible patients entered the informed consent process. Depending on their cognitive abilities (quantified using a mental status questionnaire), they were individually, or in the presence of a designated proxy, informed about the diagnosis, the proposed treatment and the randomised trial. Patients were only included by the surgeon on call if they consented in writing or – in the case of cognitive impairment – gave their verbal assent with written consent by a designated proxy according to the Swiss civil code (Art. 378) or a legal guardian.
Consent for publication
Not applicable.
Competing interests
Rachel Rosenthal has been an employee of F. Hoffmann-La Roche Ltd. since May 01, 2014. The present study was designed before Rachel Rosenthal joined F. Hoffmann-La Roche Ltd. and has no connection to her employment by the company. Rachel Rosenthal continues to be affiliated with the University of Basel. The other authors have no conflict of interest to declare.
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