Clinical trial NCT02854566: Periprosthetic Fractures of the Femur Treated by Osteosynthesis
Official title: Periprosthetic Fractures of the Femur Treated by Osteosynthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periprosthetic Fracture of the Femur
Keywords: periprosthetic fracture of the femur
hip prosthesis
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Periprosthetic fractures of the femur treated by osteosynthesis

Brief summary: Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.

The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).

Exclusion Criteria:

* Death during surgery.

Primary outcomes:
measure: Age
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Sex
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Body Mass Index
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Prosthesis type
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Type of fracture
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Femoral component
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Time between 1st surgery and fracture
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
measure: Fracture healing
timeFrame: 10 months after surgery
measure: Mortality rate
timeFrame: 10 months after surgery
measure: Complications rate
timeFrame: 10 months after surgery
measure: ASA score
timeFrame: During surgery (up to 2 hours)
measure: Blood loss
timeFrame: During surgery (up to 2 hours)
Secondary outcomes:
measure: Laterality
timeFrame: Up to 2-3 days before surgery (pre-surgery radiography)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Dragos Schiopu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Tamas Illes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaski GE, Scully SP. In brief: classifications in brief: Vancouver classification of postoperative periprosthetic femur fractures. Clin Orthop Relat Res. 2011 May;469(5):1507-10. doi: 10.1007/s11999-010-1532-0. No abstract available.
citation: Duncan CP, Haddad FS. The Unified Classification System (UCS): improving our understanding of periprosthetic fractures. Bone Joint J. 2014 Jun;96-B(6):713-6. doi: 10.1302/0301-620X.96B6.34040.
citation: Lindahl H, Malchau H, Oden A, Garellick G. Risk factors for failure after treatment of a periprosthetic fracture of the femur. J Bone Joint Surg Br. 2006 Jan;88(1):26-30. doi: 10.1302/0301-620X.88B1.17029.
citation: Laurer HL, Wutzler S, Possner S, Geiger EV, El Saman A, Marzi I, Frank J. Outcome after operative treatment of Vancouver type B1 and C periprosthetic femoral fractures: open reduction and internal fixation versus revision arthroplasty. Arch Orthop Trauma Surg. 2011 Jul;131(7):983-9. doi: 10.1007/s00402-011-1272-y. Epub 2011 Feb 18.
citation: Learmonth ID. The management of periprosthetic fractures around the femoral stem. J Bone Joint Surg Br. 2004 Jan;86(1):13-9. No abstract available.
citation: Corten K, Vanrykel F, Bellemans J, Frederix PR, Simon JP, Broos PL. An algorithm for the surgical treatment of periprosthetic fractures of the femur around a well-fixed femoral component. J Bone Joint Surg Br. 2009 Nov;91(11):1424-30. doi: 10.1302/0301-620X.91B11.22292.
citation: Capello WN, D'Antonio JA, Naughton M. Periprosthetic fractures around a cementless hydroxyapatite-coated implant: a new fracture pattern is described. Clin Orthop Relat Res. 2014 Feb;472(2):604-10. doi: 10.1007/s11999-013-3137-x.
citation: Niikura T, Sakurai A, Oe K, Shibanuma N, Tsunoda M, Maruo A, Shoda E, Lee SY, Sakai Y, Kurosaka M. Clinical and radiological results of locking plate fixation for periprosthetic femoral fractures around hip arthroplasties: a retrospective multi-center study. J Orthop Sci. 2014 Nov;19(6):984-90. doi: 10.1007/s00776-014-0622-3. Epub 2014 Aug 22.
citation: Choo SK, Kim Y, Shin MJ, Oh HK. Conservative treatment after failure of internal fixation for periprosthetic femoral fractures: a report of two cases. Arch Orthop Trauma Surg. 2015 Jun;135(6):773-9. doi: 10.1007/s00402-015-2210-1. Epub 2015 Apr 18.
citation: Baba T, Kaneko K, Shitoto K, Futamura K, Maruyama Y. Comparison of therapeutic outcomes of periprosthetic femoral fracture between treatments employing locking and conventional plates. Eur J Orthop Surg Traumatol. 2013 May;23(4):437-41. doi: 10.1007/s00590-012-1005-0. Epub 2012 May 17.
citation: Muller FJ, Galler M, Fuchtmeier B. Clinical and radiological results of patients treated with orthogonal double plating for periprosthetic femoral fractures. Int Orthop. 2014 Dec;38(12):2469-72. doi: 10.1007/s00264-014-2464-1. Epub 2014 Aug 12.
citation: Moloney GB, Westrick ER, Siska PA, Tarkin IS. Treatment of periprosthetic femur fractures around a well-fixed hip arthroplasty implant: span the whole bone. Arch Orthop Trauma Surg. 2014 Jan;134(1):9-14. doi: 10.1007/s00402-013-1883-6. Epub 2013 Nov 20.