Postoperative Periprosthetic Fractures in Hip Fracture Patients: Exeter vs Anatomic SP2 Lubinus Stem

Femoral Neck Fractures Clinical Trial

— PPFEvL  

Official title:

Postoperative Periprosthetic Fractures in Hip Fracture Patients: Comparison of the Exeter Stem and the Anatomic SP2 Lubinus Stem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326271
• Other study ID #: Multicenter_PPF
• Status: Completed
• Start date: May 4, 2016
• Est. completion date: October 11, 2017

Study information

• Verified date: October 2019
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recent studies have indicated a high incidence of postoperative periprosthetic femoral fracture in elderly patients treated with two commonly used cemented polished, tapered femoral stems. The aim of this study was to compare the prevalence and incidence rate of PPF in a cohort of elderly with femoral neck fractures (FNF) treated with either a collarless, polished, tapered stem (Exeter) or an anatomic matte stem (Lubinus SP 2).

Patients and Methods In a multicentre retrospective cohort study 2529 patients 60 years and above, with a FNF as indication for primary surgery with a cemented hip arthroplasty were included. Patients were treated either with a polished tapered Exeter stem or a matte anatomic Lubinus SP12 stem according to the surgeons preference or to the praxis of the present department.

The incidence of perprosthetic femoral fractures Hip-related complications and repeat surgery were assessed at a minimum follow-up of 2 years postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2527
• Est. completion date: October 11, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Femoral neck fracture

• Treated with hip arthroplasty with Exeter or SP2 stem

Exclusion Criteria:

• Patological fracture

• Other typ of stem

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Periprosthetic Fractures

Intervention

Procedure:
• Exeter stem
Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture
• Lubinus SP2 stem
Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sundsvall Hospital	Karolinska Institutet, Sunderby Hospital

References & Publications (4)

Brodén C, Mukka S, Muren O, Eisler T, Boden H, Stark A, Sköldenberg O. High risk of early periprosthetic fractures after primary hip arthroplasty in elderly patients using a cemented, tapered, polished stem. Acta Orthop. 2015 Apr;86(2):169-74. doi: 10.3109/17453674.2014.971388. Epub 2014 Oct 3. — View Citation

Inngul C, Enocson A. Postoperative periprosthetic fractures in patients with an Exeter stem due to a femoral neck fracture: cumulative incidence and surgical outcome. Int Orthop. 2015 Sep;39(9):1683-8. doi: 10.1007/s00264-014-2570-0. Epub 2014 Oct 24. — View Citation

Märdian S, Perka C, Schaser KD, Gruner J, Scheel F, Schwabe P. Cardiac disease and advanced age increase the mortality risk following surgery for periprosthetic femoral fractures. Bone Joint J. 2017 Jul;99-B(7):921-926. doi: 10.1302/0301-620X.99B7.BJJ-2016-0974.R1. — View Citation

Mukka S, Mellner C, Knutsson B, Sayed-Noor A, Sköldenberg O. Substantially higher prevalence of postoperative peri-prosthetic fractures in octogenarians with hip fractures operated with a cemented, polished tapered stem rather than an anatomic stem. Acta Orthop. 2016 Jun;87(3):257-61. doi: 10.3109/17453674.2016.1162898. Epub 2016 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periprosthetic femoral fractures	The incidence of postoperative periprosthetic femoral fractures are compared between the two groups studied (patients treated with Exeter stem or Lubinus SP2 stem. The hypothesis that the type of stem affects the incidence of periprosthetic femoral fractures are studied. The comparison will be analysed using cox proportional hazards or poisson regression analysis.	2006-2014
Secondary	Riskfactors for periprosthetic fractures	Sex (male or female), age (years), ASA class (1-2 or 3-4), Exeter stem size (0-2, 3-4, 5-6) and surgical approach (direct lateral or posterolateral) type of stem used (Lubinus Sp2 or Exeter stem)	2006-2014