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

NCT ID: NCT01481896

Last Updated: 2013-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Osteoarthritis

Keywords

Hip replacement; Metal-on-metal bearings; Osteolysis; Metal ion levels; Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Metal-on-metal primary total hip arthroplasty (DePuy )

Intervention Type: DEVICE

Replacement of a patient's native hip with an artificial implant featuring a metal-on-metal articulation

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

DePuy Pinnacle acetabular cup; DePuy Ultamet metal liner; DePuy 36-mm femoral head

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert H. Hopper, Jr.

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert H Hopper, Jr., PhD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Research Institute

Locations

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Countries

United States

References

MacDonald SJ. Metal-on-metal total hip arthroplasty: the concerns. Clin Orthop Relat Res. 2004 Dec;(429):86-93. doi: 10.1097/01.blo.0000150309.48474.8b.

Reference Type: BACKGROUND

PMID: 15577471 (View on PubMed)

Bozic KJ, Kurtz S, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of bearing surface usage in total hip arthroplasty in the United States. J Bone Joint Surg Am. 2009 Jul;91(7):1614-20. doi: 10.2106/JBJS.H.01220.

Reference Type: BACKGROUND

PMID: 19571083 (View on PubMed)

Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.

Reference Type: BACKGROUND

PMID: 19554385 (View on PubMed)

Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance of metal-on-metal joints: Part II: design. J Arthroplasty. 2004 Dec;19(8 Suppl 3):124-30. doi: 10.1016/j.arth.2004.09.016.

Reference Type: BACKGROUND

PMID: 15578566 (View on PubMed)

Rieker CB, Schon R, Kottig P. Development and validation of a second-generation metal-on-metal bearing: laboratory studies and analysis of retrievals. J Arthroplasty. 2004 Dec;19(8 Suppl 3):5-11. doi: 10.1016/j.arth.2004.09.017.

Reference Type: BACKGROUND

PMID: 15578545 (View on PubMed)

Silva M, Heisel C, Schmalzried TP. Metal-on-metal total hip replacement. Clin Orthop Relat Res. 2005 Jan;(430):53-61. doi: 10.1097/01.blo.0000149995.84350.d7.

Reference Type: BACKGROUND

PMID: 15662304 (View on PubMed)

Beaule PE, Campbell P, Mirra J, Hooper JC, Schmalzried TP. Osteolysis in a cementless, second generation metal-on-metal hip replacement. Clin Orthop Relat Res. 2001 May;(386):159-65. doi: 10.1097/00003086-200105000-00020.

Reference Type: BACKGROUND

PMID: 11347829 (View on PubMed)

Willert HG, Buchhorn GH, Fayyazi A, Flury R, Windler M, Koster G, Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A clinical and histomorphological study. J Bone Joint Surg Am. 2005 Jan;87(1):28-36. doi: 10.2106/JBJS.A.02039pp.

Reference Type: BACKGROUND

PMID: 15637030 (View on PubMed)

Engh CA Jr, Ho H, Engh CA. Metal-on-metal hip arthroplasty: does early clinical outcome justify the chance of an adverse local tissue reaction? Clin Orthop Relat Res. 2010 Feb;468(2):406-12. doi: 10.1007/s11999-009-1063-8. Epub 2009 Sep 1.

Reference Type: BACKGROUND

PMID: 19727991 (View on PubMed)

Related Links

http://aori.org

Website for Anderson Orthopaedic Research Institute

Other Identifiers

Study #09013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AORI2011-0100

Identifier Type: -

Identifier Source: org_study_id