NCT02854566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4.5 years

First QC Date

August 1, 2016

Last Update Submit

July 19, 2022

Conditions

Periprosthetic Fracture of the Femur

Keywords

periprosthetic fracture of the femurhip prosthesis

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • Laterality

    Up to 2-3 days before surgery (pre-surgery radiography)

Study Arms (1)

periprosthetic fractures of the femur

periprosthetic fractures of the femur treated by osteosynthesis

Device: osteosynthesis

Interventions

osteosynthesisDEVICE

Fracture reduction and fixation with screws/plates/cables (standard of care)

periprosthetic fractures of the femur

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Periprosthetic fractures of the femur treated by osteosynthesis

You may qualify if:

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

You may not qualify if:

  • Death during surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (12)

  • 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.

    PMID: 20809166BACKGROUND

  • 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.

    PMID: 24891568BACKGROUND

  • 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.

    PMID: 16365115BACKGROUND

  • 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.

    PMID: 21331551BACKGROUND

  • 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.

    PMID: 14765858BACKGROUND

  • 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.

    PMID: 19880884BACKGROUND

  • 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.

    PMID: 23836241BACKGROUND

  • 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.

    PMID: 25145998BACKGROUND

  • 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.

    PMID: 25894000BACKGROUND

  • 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.

    PMID: 23412148BACKGROUND

  • 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.

    PMID: 25109478BACKGROUND

  • 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.

    PMID: 24253261BACKGROUND

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Dragos Schiopu, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

  • Tamas Illes, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 3, 2016

Study Start

June 1, 2016

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

BE(1)