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CompletedNCT00317889Updated Dec 19, 2020

Compaction Total Hip Arthroplasty (THA) Bilateral

An interventional study of Bone preparation technique: compaction and Bone preparation technique: broaching in Coxarthrosis, sponsored by Northern Orthopaedic Division, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-19.

Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.

Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.

02

Conditions studied

  • Coxarthrosis

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Keywords

  • THA
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with primary arthritis in the hip
  • Patients with sufficient bone density to allow uncemented implantation of a femoral component
  • Informed patient consent in writing

Exclusion criteria

Exclusion Criteria:

  • Patients with neuromuscular or vascular disease in the affected leg
  • Patients found upon operation to be unsuited for uncemented acetabulum component
  • Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
  • Patients with fracture sequelae
  • Female patients of childbearing capacity
  • Hip joint dysplasia
  • Sequelae to previous hip joint disorder in childhood.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Compaction

    Compaction technique for femoral bone preparation prior to cementless femoral stem insertion.

    Procedure: Bone preparation technique: compaction

  • Active comparator
    Broaching

    Broaching technique for femoral bone preparation prior to cementless femoral stem insertion.

    Procedure: Bone preparation technique: broaching

Interventions

  • ProcedureBone preparation technique: compaction

    Also known as: No other names.

  • ProcedureBone preparation technique: broaching

    Also known as: No other names.

06

What researchers measure

Primary outcomes

  1. Radiostereometric analysis

    Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis

    Time frame: 5 and 10 years follow-up

Secondary outcomes

  1. Periprosthetic bone mineral density

    Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)

    Time frame: 5 years follow-up

Other outcomes

  1. Questionnaire

    Questionnaire of hip function

    Time frame: 5 years follow-up

07

Study locations

1 site
  • Northern Orthopaedic Division
    Aalborg And Farsø, Aalborg 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00317889
Lead sponsor
Northern Orthopaedic Division, Denmark
Responsible party
Sponsor
First posted
Apr 25, 2006
Start date
May 2001
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Dec 19, 2020

Study contacts

Søren Kold, MD
principal investigator · Northern Orthopaedic Division
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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