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CompletedNCT00962351Updated Aug 17, 2015

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

An interventional study of Total Hip Replacement in Non-inflammatory Degenerative Joint Disease, sponsored by Anderson Orthopaedic Research Institute. Completed at 2 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-17.

Sponsored by Anderson Orthopaedic Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Non-inflammatory Degenerative Joint Disease

Keywords

  • total hip replacement
  • primary cementless total hip arthroplasty
  • metal ion
  • metal-on-metal
03

In context

Lead sponsor

Anderson Orthopaedic Research Institute is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Other
    Metal-on-Polyethylene

    Procedure: Total Hip Replacement

  • Other
    Metal-on-Metal, 28mm femoral head

    Procedure: Total Hip Replacement

  • Other
    Metal-on-Metal, 36mm femoral head

    Procedure: Total Hip Replacement

Interventions

  • ProcedureTotal Hip Replacement
06

What researchers measure

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

07

Study locations

2 sites
  • Anderson Orthopaedic Research Institute
    Alexandria, Virginia 22306, United States
  • Department of Orthopaedic Surgery, University of Western Ontario
    London, Ontario N6A5A5, Canada
08

References and documents

Publications

  • Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15. PubMed 18855089 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2003, a primary completion of Oct 2010 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2009
First posted
Aug 20, 2009
Start
Oct 2003
Primary completionActual
Oct 2010
CompletionActual
Oct 2013
Last update
Aug 17, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00962351
Lead sponsor
Anderson Orthopaedic Research Institute
Collaborators
University of Western Ontario, Canada, DePuy Orthopaedics
Responsible party
C. Anderson Engh, Jr., MD (Orthopaedic Surgeon, Anderson Orthopaedic Research Institute) — Principal investigator
First posted
Aug 20, 2009
Start date
Oct 2003
Primary completion
Oct 2010
Completion
Oct 2013
Last update
Aug 17, 2015

Study contacts

C. Anderson Engh, Jr., MD
principal investigator · Anderson Orthopaedic Research Institute
Steven J. MacDonald, MD
principal investigator · Department of Orthopaedic Surgery, University of Western Ontario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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