Radiostereometric Analysis of Acetabular Wear and Peripro... | NCT00607516

Studies
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties

NCT00607516

Sponsor

Ullevaal University Hospital

Status

Unknown status

Last Update Posted

Jun 24, 2009Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Femoral Neck Fractures
Bone Density
Acetabular Wear
Hemiarthroplasty

Interventions

Cemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
REK I (Norway) 151-05-04061

Status Module

Record Verification Date

Feb 2007

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

Mar 2006

Primary Completion Date

Jan 2009Estimated

Completion Date

Jan 2009Estimated

First Submitted Date

Jan 22, 2008

First Submission Date that Met QC Criteria

Jan 22, 2008

First Posted Date

Feb 5, 2008Estimated

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

Jun 23, 2009

Last Update Posted Date

Jun 24, 2009Estimated

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

Substudy and continuation of HEMI-SAB-UUS (NCT00491673)

Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.

Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

Detailed Description

Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.

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

22Actual

Arms/Interventions Module

Arm Groups

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

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acetabular wear in mm		1 year
Loss of bone mineral density (BMD)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Functional outcome including pain (Harris Hip Score)		1 year
Activities Of Daily Living (Barthels ADL-Index)		1 year
Quality Of Life (EQ-5D)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Femoral neck fracture
65 years or older
Able to walk independently

Exclusion Criteria:

Cognitive dysfunction
Infection
Fracture caused by malignant disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 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 Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ullevål University Hospital		Oslo	Oslo	0407	Norway

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005265	Femoral Neck Fractures
D050723	Fractures, Bone
D010024	Osteoporosis

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases