Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty

Hip Fractures Clinical Trial

— CHANCE  

Official title:

Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02247791
• Other study ID #: CHANCE
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2013
• Last updated: January 27, 2016
• Start date: September 2009
• Est. completion date: September 2024

Study information

• Verified date: January 2016
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

Description:

The study will randomize patients between an uncemented and cemented stem

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: September 2024
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 79 Years

Eligibility

Inclusion Criteria:

• Acute Displaced femoral neck fracture

• Subject is aged between 65-79 years

• Independent walker with or without walking aides

• Subject is able and capable of providing consent to participate in the study

Exclusion Criteria:

• Patients with Rheumatoid Arthritis

• Patients with an impaired cognitive dysfunction

• Patients with Pathological fractures

• Patients with substance abuse

• Patients with fracture older than 36-hours on arrival at the A&E

• Patients suffering from cancer

• Patients determined by principal investigator to be unsuitable for inclusion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fractures

Intervention

Procedure:
• Uncemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
• Cemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Biomet, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip related complication rate	All hip-related complications	2 years	Yes
Primary	Health-related Quality of Life	Health related quality of life	2 years	No
Secondary	Duration of surgery		2 years	Yes
Secondary	Intraoperative bleeding		2 years	Yes
Secondary	Hip function	Measured with Harris hip score	2 years	No