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

NCT02591342 | Completed

• 1 other identifier: SM_IV
• Study Type: observational
• Target: 1,014
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hip Fracture; Femoral Neck Fracture; Periprosthetic Femoral Fracture

Keywords

femoral neck fracture; hip arthroplasty; complication; periprosthetic femoral fracture

Outcome Measures

Primary Outcomes (1)

• Incidence of periprosthetic femoral fracture

  2 years

Secondary Outcomes (3)

• Type of periprosthetic femoral fracture

  2 years

• Type of complications after surgery for periprosthetic femoral fracture

  2 years

• Mortality

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Secondary arthroplasty due to sequel after femoral fracture

Sponsors & Collaborators

• Sundsvall Hospital: lead

Related Publications (3)

• 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.

  PMID: 25280133 BACKGROUND

• 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.

  PMID: 25341951 BACKGROUND

• 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.

  PMID: 25274795 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Sebastian Mukka, M.D, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: September 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05