A Prospective Randomized Trial of Uncemented Versus Cemen... | NCT00491673

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 25, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2010

Last Update Posted Date

Sep 24, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ullevaal University HospitalOTHER

Collaborators

Name	Class
Asker & Baerum Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly

No definite conclusions have been made in regards to what kind of arthroplasty is favourable

Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.

Cementless implants are associated with increased postoperative pain and decreased walking ability.

This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years

Detailed Description

Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group

Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.

Recorded after surgery:

Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision

Recorded at discharge, 3 months, 1 year and 5 years:

X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids

Publication: International orthopaedic journal.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uncemented	Active Comparator	Uncemented primary bipolar hemiarthroplasty of the hip	Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
Cemented	Active Comparator	Cemented primary bipolar hemiarthroplasty of the hip	Procedure: Cemented primary bipolar hemiarthroplasty of the hip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Uncemented primary bipolar hemiarthroplasty of the hip	Procedure	Uncemented primary bipolar hemiarthroplasty of the hip	Uncemented

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional outcome including pain (Harris Hip Score)		5 years

Secondary Outcomes

Measure	Description	Time Frame
All Cause Mortality		5 years
Activities Of Daily Living (Barthels ADL-Index)		5 years
Quality Of Life (EQ-5D)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dislocated intracapsular femoral neck fracture
≥ 70 years old

Exclusion Criteria:

Pathological fracture
Systemic or local infection
Short life expectancy/not mobile at all
Symptomatic coxarthrosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Nordsletten, Prof MD PhD	Ullevål University Hospital, University of Oslo	Study Chair
Wender Figved, MD, PhD	Asker and Baerum Hospital	Principal Investigator
Lars Nordsletten, Prof MD PhD	Ullevål University Hospital, University of Oslo	Study Director
Ellen Langslet, MD	Ullevaal University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ullevål University Hospital		Oslo	Oslo	0407	Norway
Sykehuset Asker And Baerum

References Module

Citations

Not provided

ID	Term
D005265	Femoral Neck Fractures
D050723	Fractures, Bone

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries