NCT01481896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 9, 2013

Completed
Last Updated

October 9, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

November 23, 2011

Results QC Date

June 30, 2012

Last Update Submit

August 1, 2013

Conditions

Osteoarthritis

Keywords

Hip replacementMetal-on-metal bearingsOsteolysisMetal ion levelsOutcome

Outcome Measures

Primary Outcomes (1)

  • Metal Ion Levels Per Participant

    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.

    At a mean of 4.2 years after primary total hip arthroplasty

Secondary Outcomes (6)

  • Cup Orientation Per Hip

    On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty

  • Harris Hip Score Per Hip

    At a mean of 5.6 years after primary total hip arthroplasty

  • Osteolysis Per Hip

    At a mean of 5.6 years after primary total hip arthroplasty

  • Implant Stability Per Hip

    At a mean of 5.6 years after primary total hip arthroplasty

  • Component Revision Per Hip

    At a mean of 6.7 years after primary total hip arthroplasty

  • +1 more secondary outcomes

Study Arms (1)

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 )

Interventions

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

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

Also known as: DePuy Pinnacle acetabular cup, DePuy Ultamet metal liner, DePuy 36-mm femoral head
Metal-on-Metal Total Hip Arthroplasties

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Revision total hip arthroplasties
  • Primary total hip arthroplasties using Ultamet liners coupled with 28-mm femoral heads

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Related Publications (9)

  • 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.

    PMID: 15577471BACKGROUND

  • 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.

    PMID: 19571083BACKGROUND

  • 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.

    PMID: 19554385BACKGROUND

  • 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.

    PMID: 15578566BACKGROUND

  • 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.

    PMID: 15578545BACKGROUND

  • 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.

    PMID: 15662304BACKGROUND

  • 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.

    PMID: 11347829BACKGROUND

  • 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.

    PMID: 15637030BACKGROUND

  • 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.

    PMID: 19727991BACKGROUND

Related Links

MeSH Terms

Conditions

OsteoarthritisOsteolysis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone ResorptionBone Diseases

Results Point of Contact

Title
Robert H. Hopper, Jr., PhD
Organization
Anderson Orthopaedic Research Institute
research@aori.org
(703) 619-4411

Study Officials

  • Robert H Hopper, Jr., PhD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 30, 2011

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 9, 2013

Results First Posted

October 9, 2013

Record last verified: 2013-08

Locations

US(1)