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

NCT ID: NCT02591342

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fracture Femoral Neck Fracture Periprosthetic Femoral Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPT stem

Patients treated with a polished, tapered femoral stem as a hip arthroplasty for a displaced femoral neck fracture

No interventions assigned to this group

SP2 stem

Patients treated with a anatomic femoral stem as a hip arthroplasty for a displaced femoral neck fracture

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Displaced femoral neck fracture
* Treated with a primary hip arthroplasty

Exclusion Criteria

* Secondary arthroplasty due to sequel after femoral fracture
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sundsvall Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Mukka, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

UmeƄ University

References

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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.

Reference Type BACKGROUND
PMID: 25280133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25341951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25274795 (View on PubMed)

Other Identifiers

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SM_IV

Identifier Type: -

Identifier Source: org_study_id

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