A Five-Year Metal-on-Metal Retrospective Clinical Study

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Robert H. Hopper, Jr., Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01481896
First received: November 23, 2011
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

This retrospective study will review the Anderson Orthopaedic Institute's initial experience among a consecutive series of 126 patients who had primary total hip arthroplasty using a metal-on-metal articulation consisting of a DePuy Pinnacle cup with an Ultamet liner coupled with a 36-mm cobalt-chrome alloy femoral head. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated.


Condition Intervention
Osteoarthritis
Device: Metal-on-metal primary total hip arthroplasty (DePuy )

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Five-Year Metal-on-Metal Retrospective Clinical Study

Resource links provided by NLM:


Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • Metal Ion Levels Per Participant [ Time Frame: At a mean of 4.2 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.


Secondary Outcome Measures:
  • Cup Orientation Per Hip [ Time Frame: On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip.

  • Harris Hip Score Per Hip [ Time Frame: At a mean of 5.6 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip.

  • Osteolysis Per Hip [ Time Frame: At a mean of 5.6 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip.

  • Implant Stability Per Hip [ Time Frame: At a mean of 5.6 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip.

  • Component Revision Per Hip [ Time Frame: At a mean of 6.7 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip.

  • Patient Satisfaction Per Hip [ Time Frame: At a mean of 5.6 years after primary total hip arthroplasty ] [ Designated as safety issue: No ]
    Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip.


Enrollment: 126
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metal-on-Metal Total Hip Arthroplasties
Consecutive series of patients who had metal-on-metal primary total hip arthroplasty performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
Device: Metal-on-metal primary total hip arthroplasty (DePuy )
Replacement of a patient's native hip with an artificial implant featuring a metal-on-metal articulation
Other Names:
  • DePuy Pinnacle acetabular cup
  • DePuy Ultamet metal liner
  • DePuy 36-mm femoral head

Detailed Description:

Metal-on-metal bearings for total hip arthroplasty are an alternative to traditional polyethylene bearing surfaces and hip simulators studies have shown that metal-on-metal bearings have lower wear than metal-on-polyethylene bearings. In addition, simulator studies indicate that the amount of wear decreases as head size increases allowing the use of larger head diameters than possible with other bearing surfaces. Since dislocation is currently the most common reason for reoperation in the United States, representing 22.5% of hip revisions, the combination of low wear and larger head sizes to reduce dislocation hold the promise of improving outcome among total hip arthroplasty patients. While there are potential advantages to metal-on-metal bearings, a few concerns have been noted in the literature. Although the total volume of wear is low with these bearings, the articulation generates metal debris that may be related to patient and surgical factors such as implant positioning. Despite a reduced wear volume, there is also the possibility that an increased bioreactivity associated with metal debris might induce an osteolytic response or local tissue hypersensitivity reaction.

This study will retrospectively review the outcome of a consecutive series of 126 patients who had 131 primary THAs performed between April 2001 and November 2002 at the Anderson Clinic with a Pinnacle acetabular cup, an Ultamet insert and a 36-mm cobalt-chrome alloy femoral head. These total hip arthroplasties represent the Anderson Orthopaedic Institute's in initial experience with this implant. The relationship between metal ion levels, cup orientation, osteolysis, radiographic implant stability and clinical outcome measures including component revision, complications, patient satisfaction and Harris Hip Scores will be evaluated. The outcome data from our analysis will also be compared with the data from other published series with metal-on-metal bearing surfaces. Serial radiographs obtained as part of routine post-operative care will be used to evaluate osteolysis, implant stability and radiographic complications such as periprosthetic fracture. The area of each osteolytic region will be measured on the AP pelvic x-ray using Martell's Hip Analysis Suite. Computed tomography (CT) scans obtained as part of routine follow-up will be also analyzed to identify regions of acetabular osteolysis. The volume and location of each osteolytic defect identified on CT will be evaluated using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). A three-dimensional (3D) reconstruction of the pelvis, cup and acetabular osteolytic lesions will also be generated from the CT image data. This reconstruction will be oriented to simulate the AP pelvic radiographic view. Cobalt and chromium ion level data will be compiled for patients who had blood drawn to evaluate metal ion levels. The mean and median blood metal-ion levels for these patients will be calculated and the results will be compared to the metal-ion levels reported in the literature.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A consecutive series of patients who had primary total hip arthroplasties performed at the Anderson Clinic using DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.

Criteria

Inclusion Criteria:

  • Primary total hip arthroplasty patients who had surgery between April 2001 and November 2002 who were implanted with a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36mm cobalt-chrome alloy femoral head

Exclusion Criteria:

  • Revision total hip arthroplasties
  • Primary total hip arthroplasties using Ultamet liners coupled with 28-mm femoral heads
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481896

Locations
United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22306
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
DePuy Orthopaedics
Investigators
Principal Investigator: Robert H Hopper, Jr., PhD Anderson Orthopaedic Research Institute
  More Information

Additional Information:
Publications:

Responsible Party: Robert H. Hopper, Jr., Director, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01481896     History of Changes
Other Study ID Numbers: AORI2011-0100, Study #09013
Study First Received: November 23, 2011
Results First Received: June 30, 2012
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
Hip replacement
Metal-on-metal bearings
Osteolysis
Metal ion levels
Outcome

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014