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OpenTrials
Completed

NCT Number: NCT01359540

Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs

This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Diseases Bone Diseases, Metabolic Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum age 20 years, maximum age 80 years
  • Osteoarthritis of the hip
  • Elective THA
  • Signed Informed Consent

Exclusion criteria

  • Osteoporosis
  • Revisions
  • Clinically obese (>40 body mass index [BMI])
  • Femoral dysplasia
  • Trochanteric osteotomy
  • Inflammatory arthritis
  • Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
  • Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of other investigational agent in the last 30 days
  • Unable to sign Informed Consent

Treatment and study plan

OMNI Apex Modular™ Hip Device

Device

OMNI Apex ARC™ Hip Device

Device

Primary outcomes

  1. Femoral bone mineral density

    Time frame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

    Change in bone mineral density (BMD) as measured by DXA imaging.

Secondary outcomes

  1. Harris Hip Score (HHS)

    Time frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

    Hip functional outcomes will be assessed using the Harris Hip Score.

Sponsors and collaborators

Lead sponsor

Spokane Joint Replacement Center

Other

Registry information

Official study title

A Dual Energy X-Ray Absorptiometry (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
May 24, 2011
Registry last updated
Apr 26, 2019

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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