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Completed

NCT Number: NCT00317889

Compaction Total Hip Arthroplasty (THA) Bilateral

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.

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Orthopaedic Division

Aalborg and Farsø, Aalborg, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Bone preparation technique: compaction

Procedure

Other names: No other names.

Bone preparation technique: broaching

Procedure

Other names: No other names.

Primary outcomes

  1. Radiostereometric analysis

    Time frame: 5 and 10 years follow-up

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

Secondary outcomes

  1. Periprosthetic bone mineral density

    Time frame: 5 years follow-up

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

Other outcomes

  1. Questionnaire

    Time frame: 5 years follow-up

    Questionnaire of hip function

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

Compaction THA Bilateral

Important dates

Study start
2001
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2006
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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