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

NCT03326271 | Completed

• 1 other identifier: Multicenter_PPF
• Study Type: observational
• Target: 2,527
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Femoral Neck Fractures; Periprosthetic Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Riskfactors for periprosthetic fractures

  2006-2014

Study Arms (2)

Lubinus SP2 stem

Patients treated with a cemented Lubinus SP2 stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.

Procedure: Lubinus SP2 stem

Exeter stem

Patients treated with a cemented Exeter stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.

Procedure: Exeter stem

Interventions

Exeter stem PROCEDURE

Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture

Exeter stem

Lubinus SP2 stem PROCEDURE

Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture

Lubinus SP2 stem

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients at above mentioned centers presented with a femoral neck fracture treated with hip arthroplasty between 2006-2014 were followed 2017 or until death.

You may qualify if:

• Femoral neck fracture
• Treated with hip arthroplasty with Exeter or SP2 stem

You may not qualify if:

• Patological fracture
• Other typ of stem

Sponsors & Collaborators

• Sundsvall Hospital: lead
• Sunderby Hospital: collaborator
• Karolinska Institutet: collaborator

Related Publications (5)

• 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.

  PMID: 25341951 BACKGROUND

• Mukka S, Mellner C, Knutsson B, Sayed-Noor A, Skoldenberg 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.

  PMID: 27045318 BACKGROUND

• Broden C, Mukka S, Muren O, Eisler T, Boden H, Stark A, Skoldenberg 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.

  PMID: 25280133 BACKGROUND

• Mardian 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.

  PMID: 28663398 BACKGROUND

• Mellner C, Mohammed J, Larsson M, Esberg S, Szymanski M, Hellstrom N, Chang C, Berg HE, Skoldenberg O, Knutsson B, Morberg P, Mukka S. Increased risk for postoperative periprosthetic fracture in hip fracture patients with the Exeter stem than the anatomic SP2 Lubinus stem. Eur J Trauma Emerg Surg. 2021 Jun;47(3):803-809. doi: 10.1007/s00068-019-01263-6. Epub 2019 Nov 18.

  PMID: 31740996 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Periprosthetic Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 31, 2017
• Study Start: May 4, 2016
• Primary Completion: April 1, 2017
• Study Completion: October 11, 2017
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share