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«Treatment of trochanteric and subtrochanteric hip fractures Sliding hip screw or intramedullary nail? Dissertation for the degree of philosophiae ...»

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Treatment of trochanteric and

subtrochanteric hip fractures

Sliding hip screw or intramedullary nail?

Dissertation for the degree of philosophiae doctor (PhD)

at the University of Bergen

Scientific environment

“The Intertan Study” (papers I and IV) was performed at the Orthopaedic Department,

Haukeland University Hospital (HUS), and in close teamwork with the Clinical

Research Unit and the Department of Radiology at HUS. “The Intertan Study” was

also based on a close collaboration with 4 other Norwegian hospitals; Levanger Hospital, Akershus University Hospital, Diakonhjemmet Hospital, and Vestfold Hospital.

Papers II and III were based on data from, and written together with colleagues from the Norwegian Hip Fracture Register (NHFR). This register is an integrated part of the Norwegian Arthroplasty Register (NAR) and the Orthopaedic Department, Haukeland University Hospital, Bergen Since 2009 I have been a PhD-candidate at the Department of Surgical Sciences, University of Bergen, Bergen, Norway.

List of Content

5.1 Overview, hip fractures in general ……………………………………... 12

5.2 Classification of hip fractures ………………………………………….. 13

5.3 The surgical treatment of hip fractures ………………………………… 14

5.4 The literature and current controversies ……………………………….. 16

5.5 The Intertan nail ……………………………………………………….. 18

5.6 The Norwegian Hip Fracture Register ………………………………… 19

9.1 Methodological considerations ………………………………………… 31

9.2 Results …………………………………………………………………. 34

9.3 Interpretations ………………………………………………………….. 41

11.1 Implementation of results …………………………………………….. 45

11.2 Prevention of hip fractures …………………………………………… 45

11.3 Implants and surgical treatment ……………………………………… 46

11.4 Rehabilitation ………………………………………………………… 48

1. List of abbreviations SHS Sliding hip screw TSP Trochanteric stabilizing plate IM nail Intramedullary nail RCT Randomized controlled trial AO/OTA Arbeitsgemeinshaft für Osteosyntesefragen / Orthopaedic Trauma Association NHFR Norwegian Hip Fracture Register NAR Norwegian Arthroplasty Register TAD Tip-apex distance TUG-test Timed Up & Go-test VAS Visual analogue scale HHS Harris hip score EQ-5D EuroQuol-5Dimensions (quality of life measure) n Numbers Et al. And co-workers ASA-class American Association of Anaesthesiologists classification of c

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2. Acknowledgements The first part of this thesis is based on “The Intertan Study”, initiated late 2006 and started February 2008. The process of study planning, enrolment and follow-up of nearly 700 patients in 5 different Norwegian hospitals would not have been possible without enthusiastic participation and major efforts by many good colleagues. Clinical testing, radiological assessments, recording of data, and data management required a lot of recourses at different levels in all participating hospitals, and for these efforts, I am deeply in gratitude to all colleagues at Levanger Hospital, Akershus University Hospital, Diakonhjemmet hospital, Vestfold Hospital, and Haukeland University Hospital. Those responsible for running the every day inclusion, follow-up, and documentation in these hospital;

and should be mentioned in particular Working with you has been a great pleasure, and your commitment has been invaluable.

, the manufacturer of the new TRIGEN INTERTAN Intramedullary nail, with its national chief of trauma products, was essential in bringing colleagues from different hospitals together. Without the practical and financial support from Smith & Nephew, we could not have accomplished this clinical trial. The collaboration with Smith & Nephew has solely been a positive experience, and I have been impressed by their patients through out this process.

I would not have been able to organize or complete “The Intertan study”, or this PhDthesis, without backup from my employer, the Orthopaedic Department at Haukeland University Hospital and the Head of the Department, professor. From the beginning he has encouraged me and supported this research project, and his genuine enthusiasm for research has been inspirational to me and all the colleagues in our department. Our always optimistic and positive Director of Orthopaedic Clinic, also deserves generous credit. Not only has he been paying my salary the years I have been working on this thesis, but despite limited financial resources he has also been able to expand the medical staff, and thereby facilitating more research in our department.

After starting “The Intertan Study” I was also supported with a research grant from the regional health authorities,. This grant made it possible to become a fulltime researcher for longer periods, and this certainly made my life and the premises for my research much easier. For this I am very grateful.

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Radiologist classified fractures, and even more importantly and time consuming; all x-rays were scrutinized for the quality of reduction, implant position, and any disturbance of the healing process in the radiographic follow-up of the patients. This has been an enormous effort and also a crucial part of our study, - for this I am very grateful. The collaboration with, and in particular, was also of major importance and has been a great pleasure.

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Further I am grateful to our physiotherapists for their devoted in-hospital assessment of patients and later follow-up in the outpatient clinics.

The second part of this thesis is based on data from the (NHFR), and I would like to honour the pioneers who initiated and started the Norwegian Arthroplasty Register (NAR) in the 1980’s. Later, in 2005, the hip fracture register was established after dedicated work by in particular. Without their visions, enthusiasm, and endurance, no such registries would have existed today. I am privileged to work with the staff and colleagues in the NAR/NHFR, and I hope this collaboration will persist and enable me, and also inspire others, to continue our research and efforts to improve the treatment of hip fracture patients in the future. I would also like to thank who on a daily basis report their operations to the hip fracture register. Without them, these national registries would have been worthless, -please keep up your good work.

The last years, until August 2012, I have devoted most of my time to this research projects, and to make this possible, my good friends and colleagues at the Orthopaedic Trauma Unit have taken care of all the clinical work. I am extremely glad to be a part of a unit with such good colleagues, always enthusiastic, smiling, and doing the best to optimize the treatment for each individual patient.

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Scientific writing has been the most fun, but also most challenging part of my thesis.

The collaboration with all of my co-authors has made this a great experience.

thank you for your patients and all valuable contributions during my years of struggle trying to get papers written and accepted for publication. I also highly appreciate your contributions while planning “The Intertan Study”, and the discussions with and her statistical input, have been crucial for this scientific work. In addition, two colleagues deserve special credit for taking part in all of my research from day one until the completion of this thesis.

, professor, former Head of the Orthopaedic Department, and present chairman of the NAR/NHFR board, has been my co-supervisor. Through out the years we have had many interesting discussions and I have learned a lot from you.

Whenever I have been heading in the wrong direction, you brought me, or the writing process, back on the right track. Thank you for all your efforts, scientific feedback, and inspirational discussions.

, Head of the Children’s Unit in our Department, has been my main tutor and good friend through ups and downs in research the last years. Behind his somewhat laid-back appearance, there is a knowledgeable, clear- thinking, hardworking, and dedicated scientist. Your enthusiasm for hip fracture science has been very motivating, your commitment to scientific accuracy has been impressive, and working with you these last years has been a great pleasure.

–  –  –

Finally, I am grateful to my best companion and beloved wife for 23 years, for her continuous support through out my career, and for taking good care of me and our two wonderful daughters. The three of you are the spirit in my life and remind me that there are more important things in life than hip fracture science.

3. Abstract Trochanteric and subtrochanteric fractures are usually treated with a sliding hip screw (SHS) or an intramedullary (IM) nail, and the question whether a SHS or an IM nail should be the preferred implant for all or subgroups of fractures has not come to a final conclusion. In recent years, there has been a trend towards more use of IM nails, but this trend has not been driven by better results in well designed clinical trials.

Regardless of type of implant, complications have to be encountered and to which extent modern implants have improved results remains unclear.

It was our first aim to assess whether treatment with the new TRIGEN INTERTAN intramedullary nail resulted in less postoperative pain, better function, and improved quality of life for patients with trochanteric and subtrochanteric fractures compared to treatment with the SHS ( ). Surgical complications and reoperation rates were also assessed.

Secondly, we wanted to compare postoperative pain, function, quality of life, and reoperation rates for patients operated with IM nails and SHS for different subgroups of trochanteric and subtrochanteric fractures at a national level.

684 elderly patients with trochanteric and subtrochanteric fractures were included and treated with a SHS or the Intertan nail in a multicenter randomized controlled trial (RCT). The patients were assessed during hospital stay and at 3 and 12 months postoperatively. The 159 patients with reverse oblique trochanteric (AO/OTA type A3) and subtrochanteric fractures were separately analyzed and discussed in depth.

Using data from the Norwegian Hip Fracture Register in papers II and III, we analyzed 7643 operations for simple two-part trochanteric fractures (AO/OTA type A1) and 2716 operations for reverse oblique and subtrochanteric fractures after treatment with either a SHS or an IM nail.

As presented in patients operated with the Intertan nail had slightly less pain at early postoperative mobilization compared to those operated with a SHS, but we found no difference at 12 months. Regardless of fracture type, mobility, hip function, quality of life, and surgical complication rates were comparable for the two groups at 12 months.

In simple two-part trochanteric fractures ( ) the SHSs had a lower complication rate compared to IM nails one year postoperatively (2.4% and 4.2% for SHS and IM nail, respectively, p = 0.001). Only minor, and clinically insignificant differences between the groups were found for pain, patient satisfaction, and quality of life.

In, conversely, we found that the patients operated with an IM nail had a significantly lower failure rate compared to the SHS one year postoperatively (3.8% vs.

6.4%, respectively, p = 0.011). Small differences regarding pain, patient satisfaction, quality of life, and mobility were also in favor of IM nailing.

:

Pain, function, quality of life, and reoperation rates were similar for the Intertan nail and the SHS in trochanteric and subtrochanteric fractures 12 months postoperatively.

Data from our hip fracture register, however, favored the SHS in simple two- part trochanteric fractures, whereas IM nails had the lower complication rate and better clinical results in reverse oblique and subtrochanteric fractures. Accordingly, a differentiated treatment algorithm based on fracture type could be considered.

4. List of publications Kjell Matre, Tarjei Vinje, Leif Ivar Havelin, Jan-Erik Gjertsen, Ove Furnes, Birgitte Espehaug, Stein-Harald Kjellevold, Jonas Meling Fevang

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Kjell Matre, Jan-Erik Gjertsen, Leif Ivar Havelin, Tarjei Vinje, Ove Furnes, Birgitte Espehaug, Jonas Meling Fevang

A PROSPECTIVE, RANDOMISED, MULTICENTRE TRIAL

COMPARING THE TRIGEN INTERTAN INTRAMEDULLARY

NAIL WITH THE SLIDING HIP SCREW IN 159 PATIENTS.

–  –  –

5. Introduction and background

5.1 Overview, hip fractures in general Hip fractures are common in the elderly, and for the individual patient a hip fracture may cause short and long term pain, impaired function, and reduced quality of life. Up to one half of the patients may not regain their prefracture walking capacity, and independent living may no longer be possible (1). The mortality after hip fractures is high, and the overall one year mortality for the elderly patients with hip fractures is approximately 20-25% (2,3).

Because of the large numbers of fractures, and patients with advanced age, hip fractures also represent a major challenge to hospitals, other health care providers, and society. In addition, due to the aging of the population the next decades, the numbers of hip fractures and health care expenses are expected to increase considerably. This will further enhance the focus on prevention of fractures and optimization of the treatment. The importance of a well-performed surgical treatment in hip fracture care is undisputable, however, treating the patients from a holistic point of view is probably even more important in order to improve the overall outcome for these patients.



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