. 2019 Nov 8;19(1):301.

doi: 10.1186/s12877-019-1324-7.

The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

Collaborators, Affiliations

Collaborators

FRAIL-HIP study group:
Lisanne Balemans, Frank W Bloemers, Janneke Bos, Jantien Brouwer, Bart J Burger, Judella O Daal, Annemarieke De Jonghe, Matthea Dijkshoorn, Michael J R Edwards, Ellen A Elbrecht, Miriam C Faes, Elvira R Flikweert, Robert D A Gaasbeek, Olivia C Geraghty, J Carel Goslings, J Han Hegeman, Mischa M Hindriks, Michel Holla, André Janse, Joris A Jansen, Simone J M Jong, Paul J C Kapitein, Y V I Jdo Kleinlugtenbelt, Barbara E Kreis, Rover Krips, Koen W W Lansink, Michiel Leijnen, Pieter H W Lubbert, M Cor Luyten, Franceso U S Mattace Raso, Marieke C Meinardi, Joris Mellema, Roland M H G Mollen, Majon Muller, Joost C Peerbooms, Kees-Jan Ponsen, Rudolf W Poolman, Miruna Popescu, Albert F Pull Ter Gunne, Bas J Punt, Gert R Roukema, Hilde I F Royen, Jeanine Schukking, Josje Snoek, Charles T Stevens, Dieneke van Asselt, Alexander H Van der Veen, Detlef Van der Velde, Bart A Van Dijkman, Paul J Van Koperen, Job L C Van Susante, Romuald Van Velde, M Remmelt Veen, Michael H J Verhofstad, Ralf W Vingerhoets, Dagmar I Vos, Hugo H Wijnen, Judith Wilmer, Jasper Winkelhagen, Johan F H Wold, Robbert A Zandbergen, G Bert Ziere

Affiliations

¹ Department of Surgery, Noordwest Ziekenhuisgroep, P.O Box 501, 1800 AM, Alkmaar, The Netherlands.
² Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
³ Department Trauma TopCare, Elisabeth-TweeSteden Ziekenhuis, P.O. Box 90151, 5000 LC, Tilburg, The Netherlands.
⁴ Department of Public Health and Primary Care, Leiden University Medical Center, Hippocratespad 21, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
⁵ Department of Orthopaedic Surgery, Dijklander Ziekenhuis (location Westfriesgasthuis), P.O. Box 600, 1620 AR, Hoorn, The Netherlands.
⁶ Department of Orthopaedic Surgery, Dijklanders Ziekenhuis (location Waterland Ziekenhuis), P.O. Box 250, 1440 AG, Purmerend, The Netherlands.
⁷ Department of Orthopaedic Surgery, Isala, P.O. Box 10400, 8000 GK, Zwolle, The Netherlands.
⁸ Department of Orthopaedic Surgery, Elisabeth-TweeSteden Ziekenhuis, P.O. Box 90151, 5000 LC, Tilburg, The Netherlands.
⁹ Department of Surgery, Isala, P.O. Box 10400, 8000 GK, Zwolle, The Netherlands.
¹⁰ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
¹¹ Geriatrics Section, Department of Internal Medicine, Amsterdam UMC location AMC, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.
¹² Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. e.vanlieshout@erasmusmc.nl.

PMID: 31703579
PMCID: PMC6839183
DOI: 10.1186/s12877-019-1324-7

The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

Pieter Joosse et al. BMC Geriatr. 2019.

. 2019 Nov 8;19(1):301.

doi: 10.1186/s12877-019-1324-7.

Authors

Collaborators

FRAIL-HIP study group:
Lisanne Balemans, Frank W Bloemers, Janneke Bos, Jantien Brouwer, Bart J Burger, Judella O Daal, Annemarieke De Jonghe, Matthea Dijkshoorn, Michael J R Edwards, Ellen A Elbrecht, Miriam C Faes, Elvira R Flikweert, Robert D A Gaasbeek, Olivia C Geraghty, J Carel Goslings, J Han Hegeman, Mischa M Hindriks, Michel Holla, André Janse, Joris A Jansen, Simone J M Jong, Paul J C Kapitein, Y V I Jdo Kleinlugtenbelt, Barbara E Kreis, Rover Krips, Koen W W Lansink, Michiel Leijnen, Pieter H W Lubbert, M Cor Luyten, Franceso U S Mattace Raso, Marieke C Meinardi, Joris Mellema, Roland M H G Mollen, Majon Muller, Joost C Peerbooms, Kees-Jan Ponsen, Rudolf W Poolman, Miruna Popescu, Albert F Pull Ter Gunne, Bas J Punt, Gert R Roukema, Hilde I F Royen, Jeanine Schukking, Josje Snoek, Charles T Stevens, Dieneke van Asselt, Alexander H Van der Veen, Detlef Van der Velde, Bart A Van Dijkman, Paul J Van Koperen, Job L C Van Susante, Romuald Van Velde, M Remmelt Veen, Michael H J Verhofstad, Ralf W Vingerhoets, Dagmar I Vos, Hugo H Wijnen, Judith Wilmer, Jasper Winkelhagen, Johan F H Wold, Robbert A Zandbergen, G Bert Ziere

Affiliations

¹ Department of Surgery, Noordwest Ziekenhuisgroep, P.O Box 501, 1800 AM, Alkmaar, The Netherlands.
² Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
³ Department Trauma TopCare, Elisabeth-TweeSteden Ziekenhuis, P.O. Box 90151, 5000 LC, Tilburg, The Netherlands.
⁴ Department of Public Health and Primary Care, Leiden University Medical Center, Hippocratespad 21, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
⁵ Department of Orthopaedic Surgery, Dijklander Ziekenhuis (location Westfriesgasthuis), P.O. Box 600, 1620 AR, Hoorn, The Netherlands.
⁶ Department of Orthopaedic Surgery, Dijklanders Ziekenhuis (location Waterland Ziekenhuis), P.O. Box 250, 1440 AG, Purmerend, The Netherlands.
⁷ Department of Orthopaedic Surgery, Isala, P.O. Box 10400, 8000 GK, Zwolle, The Netherlands.
⁸ Department of Orthopaedic Surgery, Elisabeth-TweeSteden Ziekenhuis, P.O. Box 90151, 5000 LC, Tilburg, The Netherlands.
⁹ Department of Surgery, Isala, P.O. Box 10400, 8000 GK, Zwolle, The Netherlands.
¹⁰ Department of Public Health, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
¹¹ Geriatrics Section, Department of Internal Medicine, Amsterdam UMC location AMC, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.
¹² Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands. e.vanlieshout@erasmusmc.nl.

PMID: 31703579
PMCID: PMC6839183
DOI: 10.1186/s12877-019-1324-7

Abstract

Background: Proximal femoral fractures are strongly associated with morbidity and mortality in elderly patients. Mortality is highest among frail institutionalized elderly with both physical and cognitive comorbidities who consequently have a limited life expectancy. Evidence based guidelines on whether or not to operate on these patients in the case of a proximal femoral fracture are lacking. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life as operative treatment. This study aims to determine the effect of nonoperative management versus operative management of proximal femoral fractures in a selected group of frail institutionalized elderly on the quality of life, level of pain, rate of complications, time to death, satisfaction of the patient (or proxy) and the caregiver with the management strategy, and health care consumption.

Methods: This is a multicenter, observational cohort study. Frail institutionalized elderly (70 years or older with a body mass index < 18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an American Society of Anesthesiologists score of 4 or 5), who sustained a proximal femoral fracture are eligible to participate. Patients with a pathological or periprosthetic fractures and known metastatic oncological disease will be excluded. Treatment decision will be reached following a structured shared decision process. The primary outcome is quality of life (Euro-QoL; EQ-5D-5 L). Secondary outcome measures are quality of life measured with the QUALIDEM, pain level (PACSLAC), pain medication use, treatment satisfaction of patient (or proxy) and caregivers, quality of dying (QODD), time to death, and direct medical costs. A cost-utility and cost-effectiveness analysis will be done, using the EQ-5D utility score and QUALIDEM score, respectively. Non-inferiority of nonoperative treatment is assumed with a limit of 0.15 on the EQ-5D score. Data will be acquired at 7, 14, and 30 days and at 3 and 6 months after trauma.

Discussion: The results of this study will provide insight into the true value of nonoperative treatment of proximal femoral fractures in frail elderly with a limited life expectancy. The results may be used for updating (inter)national treatment guidelines.

Trial registration: The study is registered at the Netherlands Trial Register (NTR7245; date 10-06-2018).

Keywords: Elderly; Frailty; Hip fracture; Nonoperative treatment; Nursing home; Operative treatment; Palliative care; Proximal femoral fracture; Quality of life; Surgery.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Flow of participants through the study

See this image and copyright information in PMC

References

1. Zuckerman JD. Hip fracture. N Engl J Med. 1996;334(23):1519–1525. - PubMed
1. Richtlijn proximale femurfracturen NVvH & NOV: https://richtlijnendatabase.nl/richtlijn/proximale_femurfracturen/proxim.... Accessed 23 Sept 2017.
1. www.statline.cbs.nl. Accessed 23 Sept 2017.
1. Burgers PTPW, Zielinski SM, Mailuhu AKE, Heetveld MJ, Verhofstad MHJ, Roukema GR, Patka P, Poolman RW, Van Lieshout EMM. Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients. Int Orthop. 2014;38(11):2335–2342. - PubMed
1. Gjertsen JE, Baste V, Fevang JM, Furnes O, Engesaeter LB. Quality of life following hip fractures: results from the Norwegian hip fracture register. BMC Musculoskelet Disord. 2016;17:265. - PMC - PubMed

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The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

Collaborators

Affiliations

The value of nonoperative versus operative treatment of frail institutionalized elderly patients with a proximal femoral fracture in the shade of life (FRAIL-HIP); protocol for a multicenter observational cohort study

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical