NCT02247791

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

7 years

First QC Date

October 21, 2013

Last Update Submit

January 27, 2016

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (2)

  • Hip related complication rate

    All hip-related complications

    2 years

  • Health-related Quality of Life

    Health related quality of life

    2 years

Secondary Outcomes (3)

  • Duration of surgery

    2 years

  • Intraoperative bleeding

    2 years

  • Hip function

    2 years

Study Arms (2)

Cemented femoral stem

ACTIVE COMPARATOR

Patient undergoing total hip arthroplasty surgery

Procedure: Cemented femoral stem

Uncemented femoral stem

ACTIVE COMPARATOR

Patients undergoing total hip arthroplasty

Procedure: Uncemented femoral stem

Interventions

Uncemented femoral stemPROCEDURE

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Also known as: BiMetric uncemented femoral stem
Uncemented femoral stem
Cemented femoral stemPROCEDURE

All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Also known as: CPT cemented femoral stem
Cemented femoral stem

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Stockholm, 18288, Sweden

Location

Related Publications (1)

  • Chammout G, Muren O, Boden H, Salemyr M, Skoldenberg O. Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). BMC Musculoskelet Disord. 2016 Sep 20;17(1):398. doi: 10.1186/s12891-016-1253-y.

    PMID: 27646142DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Ghazi Chammout, MD

    Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of research, Orthopaedic dept

Study Record Dates

First Submitted

October 21, 2013

First Posted

September 25, 2014

Study Start

September 1, 2009

Primary Completion

September 1, 2016

Study Completion

September 1, 2024

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

SE(1)