- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02591342
Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture
May 11, 2016 updated by: Sundsvall Hospital
Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with considerable morbidity and mortality.
Recent cohort studies have demonstrated a high incidence of PPF in elderly patients treated with two commonly used polished, tapered, collarless stems in elderly patients.
The aim of this study was to compare the rate and characteristics of PPF in a consecutive cohort of patients treated either the polished tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of age with femoral neck fracture.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
1014
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
80 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We included all patients above the age of 80 years old, operated between September 2009 and April 2015 with a primary hip arthroplasty for an acute displaced femoral neck fractures.
Patients were treated either with the cemented CPT or SP2 stems.
Description
Inclusion Criteria:
- Displaced femoral neck fracture
- Treated with a primary hip arthroplasty
Exclusion Criteria:
- Secondary arthroplasty due to sequel after femoral fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
CPT stem
Patients treated with a polished, tapered femoral stem as a hip arthroplasty for a displaced femoral neck fracture
|
SP2 stem
Patients treated with a anatomic femoral stem as a hip arthroplasty for a displaced femoral neck fracture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of periprosthetic femoral fracture
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 2 years
|
2 years
|
Type of periprosthetic femoral fracture
Time Frame: 2 years
|
2 years
|
Type of complications after surgery for periprosthetic femoral fracture
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- Thien TM, Chatziagorou G, Garellick G, Furnes O, Havelin LI, Makela K, Overgaard S, Pedersen A, Eskelinen A, Pulkkinen P, Karrholm J. Periprosthetic femoral fracture within two years after total hip replacement: analysis of 437,629 operations in the nordic arthroplasty register association database. J Bone Joint Surg Am. 2014 Oct 1;96(19):e167. doi: 10.2106/JBJS.M.00643.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 28, 2015
First Submitted That Met QC Criteria
October 28, 2015
First Posted (Estimate)
October 29, 2015
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM_IV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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