Femoral Neck FracturesPPFEvLNCT03326271
Postoperative Periprosthetic Fractures in Hip Fracture Patients: Exeter vs Anatomic SP2 Lubinus Stem
An observational study of Femoral Neck Fractures and Periprosthetic Fractures, run by Sundsvall Hospital.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Neck Fractures, Periprosthetic Fractures
- What is being tested?
- Exeter stem and Lubinus SP2 stem
- Type of treatment
- Surgery or procedure
- How many people
- 2,527 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2016to 11 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Femoral neck fracture
- Treated with hip arthroplasty with Exeter or SP2 stem
Who cannot join
- Patological fracture
- Other typ of stem
About this study
Official title: Postoperative Periprosthetic Fractures in Hip Fracture Patients: Comparison of the Exeter Stem and the Anatomic SP2 Lubinus Stem
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
- Being tested
- Exeter stem, Lubinus SP2 stem
- Medical subject headings
- Femoral Neck Fractures, Periprosthetic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exeter stemProcedure or surgery
Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture
Lubinus SP2 stemProcedure or surgery
Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture
| Study group | Role | What they receive |
|---|---|---|
| Lubinus SP2 stem | Patients treated with a cemented Lubinus SP2 stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included. Receives: 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. Receives: Procedure: Exeter stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 2006-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start4 May 2016
- Primary completion1 Apr 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunderby Hospital, Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326271
- Sponsor's protocol ID
- Multicenter_PPF
- Acronym
- PPFEvL
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2017
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data are presented.
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 25341951Mukka 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 27045318Broden 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 25280133Mardian 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 28663398Mellner 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Periprosthetic Fractures in Hip Fracture Patients: Comparison of the Exeter Stem and the Anatomic SP2 Lubinus Stem
- ClinicalTrials.gov ID
- NCT03326271
- Acronym / sponsor ID
- PPFEvL / Multicenter_PPF
- Conditions
- Femoral Neck Fractures, Periprosthetic Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,527 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Collaborators
- Sunderby Hospital, Karolinska Institutet
- Study start
- 4 May 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubinus SP2 stem | – | Procedure: Lubinus SP2 stemPatients treated with a cemented Lubinus SP2 stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included. |
| Exeter stem | – | Procedure: Exeter stemPatients treated with a cemented Exeter stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Femoral neck fracture
- Treated with hip arthroplasty with Exeter or SP2 stem
Key exclusion criteria (2 listed)
- Patological fracture
- Other typ of stem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exeter stemPatients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture | Procedure or surgery | Exeter stem |
| Lubinus SP2 stemPatients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture | Procedure or surgery | Lubinus SP2 stem |
Primary outcome
Periprosthetic femoral fractures
Time frame: 2006-2014
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.
1 secondary outcome
Riskfactors for periprosthetic fractures
Time frame: 2006-2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Background: PubMed 25341951Inngul 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.
- Background: PubMed 27045318Mukka 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.
- Background: PubMed 25280133Broden 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.
- Background: PubMed 28663398Mardian 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.
- Derived from this study: PubMed 31740996Mellner 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.
- Individual participant dataSharing planned: No. No individual data are presented.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures and Periprosthetic Fractures, run by Sundsvall Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprosthetic femoral fractures (time frame: 2006-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326271, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019.