Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture

Hip Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591342
• Other study ID #: SM_IV
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: May 11, 2016
• Start date: September 2009
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Displaced femoral neck fracture

• Treated with a primary hip arthroplasty

Exclusion Criteria:

• Secondary arthroplasty due to sequel after femoral fracture

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (3)

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

Thien TM, Chatziagorou G, Garellick G, Furnes O, Havelin LI, Mäkelä K, Overgaard S, Pedersen A, Eskelinen A, Pulkkinen P, Kärrholm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of periprosthetic femoral fracture		2 years	No
Secondary	Type of periprosthetic femoral fracture		2 years	No
Secondary	Type of complications after surgery for periprosthetic femoral fracture		2 years	No
Secondary	Mortality		2 years	No