Periprosthetic Fractures of the Femur Treated by Osteosynthesis

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.

Study Overview

• Status: Completed
• Conditions: Periprosthetic Fracture of the Femur
• Intervention / Treatment: Device: osteosynthesis

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Periprosthetic fractures of the femur treated by osteosynthesis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
periprosthetic fractures of the femur; periprosthetic fractures of the femur treated by osteosynthesis	Device: osteosynthesis; Fracture reduction and fixation with screws/plates/cables (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Demographic data	Up to 2-3 days before surgery (pre-surgery radiography)
Sex	Demographic data	Up to 2-3 days before surgery (pre-surgery radiography)
Body Mass Index	Demographic data	Up to 2-3 days before surgery (pre-surgery radiography)
Prosthesis type	PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)	Up to 2-3 days before surgery (pre-surgery radiography)
Type of fracture	Type of fracture according to the Vancouver International Classification	Up to 2-3 days before surgery (pre-surgery radiography)
Femoral component	Need for cement within the femur or not	Up to 2-3 days before surgery (pre-surgery radiography)
Time between 1st surgery and fracture	Time between 1st surgery and fracture	Up to 2-3 days before surgery (pre-surgery radiography)
Fracture healing	Healing status of the fracture (healed/not healed)	10 months after surgery
Mortality rate	Mortality rate (any causes)	10 months after surgery
Complications rate	Total complications rate (local + systemic + implant)	10 months after surgery
ASA score	ASA score	During surgery (up to 2 hours)
Blood loss	Blood loss during surgery	During surgery (up to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laterality	Prosthesis on the right or on the left side	Up to 2-3 days before surgery (pre-surgery radiography)

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Dragos Schiopu, MD, CHU Brugmann

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: hip prosthesis; periprosthetic fracture of the femur
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Periprosthetic Fractures
• Other Study ID Numbers: CHUB-Periprosthetic fractures

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No