Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty (CHANCE)

January 27, 2016 updated by: Olof Skoldenberg, Danderyd Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will randomize patients between an uncemented and cemented stem

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Danderyd Hospital

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

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cemented femoral stem
Patient undergoing total hip arthroplasty surgery
Procedure: Cemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Other Names:
  • CPT cemented femoral stem
Active Comparator: Uncemented femoral stem
Patients undergoing total hip arthroplasty
Procedure: Uncemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Other Names:
  • BiMetric uncemented femoral stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip related complication rate
Time Frame: 2 years
All hip-related complications
2 years
Health-related Quality of Life
Time Frame: 2 years
Health related quality of life
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: 2 years
2 years
Intraoperative bleeding
Time Frame: 2 years
2 years
Hip function
Time Frame: 2 years
Measured with Harris hip score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Ghazi Chammout, MD, Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden

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

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 (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHANCE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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