ClinicalTrials.gg
Sign In
CompletedNCT03326271PPFEvLUpdated Oct 24, 2019

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

An observational study in Femoral Neck Fractures and Periprosthetic Fractures, sponsored by Sundsvall Hospital. Completed. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-10-24.

Sponsored by Sundsvall Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,527
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Femoral Neck Fractures
  • Periprosthetic Fractures
03

In context

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

This study's enrollment of 2,527 is above the median of 137 across 60 observational studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Sundsvall Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patological fracture
  • Other typ of stem
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,527 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureExeter stem

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

  • ProcedureLubinus SP2 stem

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

06

What researchers measure

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.

    Time frame: 2006-2014

Secondary outcomes

  1. 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)

    Time frame: 2006-2014

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25341951 ↗
  • 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. PubMed 27045318 ↗
  • 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. PubMed 25280133 ↗
  • 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. PubMed 28663398 ↗
  • 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. PubMed 31740996 ↗

Individual participant data

Plan to share: No — No individual data are presented.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Apr 2017, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2017
First posted
Oct 31, 2017
StartActual
May 4, 2016
Primary completionActual
Apr 1, 2017
CompletionActual
Oct 11, 2017
Last update
Oct 24, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03326271
Lead sponsor
Sundsvall Hospital
Collaborators
Sunderby Hospital, Karolinska Institutet
Responsible party
Sponsor
First posted
Oct 31, 2017
Start date
May 4, 2016
Primary completion
Apr 1, 2017
Completion
Oct 11, 2017
Last update
Oct 24, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Femoral Neck Fractures →

Other studies from this sponsor

Sundsvall Hospital

Start the discussion