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Status unknownNCT00607516HEMI-RSADEXAUpdated Jun 24, 2009

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

An interventional study of Cemented primary bipolar hemiarthroplasty of the hip and Uncemented primary bipolar hemiarthroplasty of the hip in Femoral Neck Fractures, Bone Density and Acetabular Wear, sponsored by Ullevaal University Hospital. Status unknown at 1 site in Norway. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2009-06-24.

Sponsored by Ullevaal University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Femoral Neck Fractures
  • Bone Density
  • Acetabular Wear
  • Hemiarthroplasty

Keywords

  • fracture
  • arthroplasty
  • wear
  • osteoporosis
  • bone
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 22 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Ullevaal University Hospital is the lead sponsor of 76 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Femoral neck fracture
  • 65 years or older
  • Able to walk independently

Exclusion criteria

Exclusion Criteria:

  • Cognitive dysfunction
  • Infection
  • Fracture caused by malignant disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    Cemented

    Cemented primary bipolar hemiarthroplasty of the hip

    Procedure: Cemented primary bipolar hemiarthroplasty of the hip

  • Active comparator
    Uncemented

    Uncemented primary bipolar hemiarthroplasty of the hip

    Procedure: Uncemented primary bipolar hemiarthroplasty of the hip

Interventions

  • ProcedureCemented primary bipolar hemiarthroplasty of the hip

    Cemented primary bipolar hemiarthroplasty of the hip

    Also known as: Spectron, Smith & Nephew, Memphis, TN

  • ProcedureUncemented primary bipolar hemiarthroplasty of the hip

    Uncemented primary bipolar hemiarthroplasty of the hip

    Also known as: Corail, DePuy/Johnson and Johnson, United Kingdom

06

What researchers measure

Primary outcomes

  1. Acetabular wear in mm

    Time frame: 1 year

  2. Loss of bone mineral density (BMD)

    Time frame: 1 year

Secondary outcomes

  1. Functional outcome including pain (Harris Hip Score)

    Time frame: 1 year

  2. Activities Of Daily Living (Barthels ADL-Index)

    Time frame: 1 year

  3. Quality Of Life (EQ-5D)

    Time frame: 1 year

07

Study locations

1 site
  • Ullevål University Hospital
    Oslo, 0407, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00607516
Lead sponsor
Ullevaal University Hospital
First posted
Feb 5, 2008
Start date
Mar 2006
Primary completion
Jan 2009 (estimated)
Completion
Jan 2009 (estimated)
Last update
Jun 24, 2009

Study contacts

Lars Nordsletten, Prof MD PhD
study director · Ullevål University Hospital, University of Oslo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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