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Completed

NCT Number: NCT00962351

Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

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Key information

Conditions

Non-inflammatory Degenerative Joint Disease

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedic Surgery, University of Western Ontario, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing cementless primary total hip replacement
  • Receiving acetabular cup of 52mm or greater
  • Preoperative level of function and pain same as for conventional hip replacement
  • Likelihood of obtaining relief of pain and improved function
  • Full skeletal maturity
  • Ability to follow instructions
  • Good general health
  • Willing to return for follow-up evaluations
  • X-ray evaluation confirming the presence of NIDJD
  • Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

Exclusion criteria

  • Age less than 40 years or greater than 80 years at time of surgery
  • Patients templated to receive an acetabular component smaller than 52mm in diameter
  • Presence of a previous prosthetic hip replacement device in the hip joint to be operated
  • Previous girdlestone procedure or surgical fusion of the hip to be operated
  • Acute femoral neck fracture
  • Above knee amputation of the contralateral and/or ipsilateral leg
  • Patients with a diagnosis of inflammatory degenerative arthritis
  • Skeletally immature
  • Evidence of active infections that may spread to other areas of the body
  • The presence of a highly communicable disease that may limit follow-up
  • Presence of known active metastatic or neoplastic disease
  • Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
  • Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
  • Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
  • Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
  • Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
  • Any steroid therapy, local or systemic, within three months prior to surgery
  • Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
  • Patient has known allergies to metal, e.g., jewelry
  • Any patient not meeting all radiographic and clinical parameters for inclusion

Treatment and study plan

Total hip replacement

Procedure

Primary outcomes

  1. cobalt, chromium, and titanium ion levels in blood and urine

    Time frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years

Secondary outcomes

  1. Hip function

    Time frame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years

  2. Durability

    Time frame: 6 months, 1 year, 2 years, 3 years, 5 years

Sponsors and collaborators

Lead sponsor

Anderson Orthopaedic Research Institute

Other

Collaborators

  • DePuy Orthopaedics
  • University of Western Ontario, Canada

Registry information

Official study title

Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

Important dates

Study start
2003
Primary completion
2010
Study completion
2013
First posted
Aug 20, 2009
Registry last updated
Aug 17, 2015

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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