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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01481896
Enrollment
126
Registered
2011-11-30
Start date
2011-12-31
Completion date
2012-06-30
Last updated
2013-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

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

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.

Interventions

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

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

Sponsors

DePuy Orthopaedics
CollaboratorINDUSTRY
Anderson Orthopaedic Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metal Ion Levels Per ParticipantAt a mean of 4.2 years after primary total hip arthroplastyMetal 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

MeasureTime frameDescription
Harris Hip Score Per HipAt a mean of 5.6 years after primary total hip arthroplastyHarris 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 HipAt a mean of 5.6 years after primary total hip arthroplastyOsteolysis 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.
Cup Orientation Per HipOn the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplastyCup 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.
Component Revision Per HipAt a mean of 6.7 years after primary total hip arthroplastyFor 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 HipAt a mean of 5.6 years after primary total hip arthroplastyWhether 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.
Implant Stability Per HipAt a mean of 5.6 years after primary total hip arthroplastyImplant 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.

Countries

United States

Participant flow

Recruitment details

For this retrospective study, the Anderson Orthopaedic Research Institute's database was used to identify a consecutive series of the first 126 patients who had 131 primary total hip arthroplasties using a Pinnacle acetabular cup, an Ultamet metal-on-metal insert and a 36-mm cobalt-chrome alloy femoral head.

Pre-assignment details

No patient from the consecutive series of hip replacements performed between April 2001 and November 2002 was excluded.

Participants by arm

ArmCount
Metal-on-Metal Total Hip Arthroplasties
Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
131
Total131

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up12

Baseline characteristics

CharacteristicMetal-on-Metal Total Hip Arthroplasties
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
10 Participants
Age, Categorical
Between 18 and 65 years
121 Participants
Age Continuous53 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
131 participants
Sex: Female, Male
Female
57 Participants
Sex: Female, Male
Male
74 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
16 / 131
serious
Total, serious adverse events
12 / 131

Outcome results

Primary

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.

Time frame: At a mean of 4.2 years after primary total hip arthroplasty

Population: Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included.

ArmMeasureValue (MEDIAN)
Patients With Serum Cobalt LevelsMetal Ion Levels Per Participant1.4 micrograms per liter
Patients With Serum Chromium LevelsMetal Ion Levels Per Participant2.1 micrograms per liter
Secondary

Component Revision Per Hip

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.

Time frame: At a mean of 6.7 years after primary total hip arthroplasty

ArmMeasureGroupValue (NUMBER)
Patients With Serum Cobalt LevelsComponent Revision Per HipStem revision for aseptic loosening1 number of hips
Patients With Serum Cobalt LevelsComponent Revision Per HipBroken stem2 number of hips
Patients With Serum Cobalt LevelsComponent Revision Per HipLiner & head exchange for groin pain & osteolysis1 number of hips
Secondary

Cup Orientation Per Hip

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.

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

Population: Cup orientation was measured for all 131 total hip replacements included in the study population.

ArmMeasureValue (MEDIAN)
Patients With Serum Cobalt LevelsCup Orientation Per Hip39 degrees
Patients With Serum Chromium LevelsCup Orientation Per Hip19 degrees
Secondary

Harris Hip Score Per Hip

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.

Time frame: At a mean of 5.6 years after primary total hip arthroplasty

ArmMeasureValue (MEDIAN)
Patients With Serum Cobalt LevelsHarris Hip Score Per Hip95 units on a scale
Secondary

Implant Stability Per Hip

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.

Time frame: At a mean of 5.6 years after primary total hip arthroplasty

Population: All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included.

ArmMeasureGroupValue (NUMBER)
Patients With Serum Cobalt LevelsImplant Stability Per HipBone ingrown105 number of hips
Patients With Serum Cobalt LevelsImplant Stability Per HipFibrous stable2 number of hips
Patients With Serum Cobalt LevelsImplant Stability Per HipLoose1 number of hips
Patients With Serum Chromium LevelsImplant Stability Per HipBone ingrown108 number of hips
Patients With Serum Chromium LevelsImplant Stability Per HipFibrous stable0 number of hips
Patients With Serum Chromium LevelsImplant Stability Per HipLoose0 number of hips
Secondary

Osteolysis Per Hip

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.

Time frame: At a mean of 5.6 years after primary total hip arthroplasty

Population: Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included.

ArmMeasureValue (NUMBER)
Patients With Serum Cobalt LevelsOsteolysis Per Hip3 Number of hips with osteolysis
Patients With Serum Chromium LevelsOsteolysis Per Hip2 Number of hips with osteolysis
Secondary

Patient Satisfaction Per Hip

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.

Time frame: At a mean of 5.6 years after primary total hip arthroplasty

ArmMeasureGroupValue (NUMBER)
Patients With Serum Cobalt LevelsPatient Satisfaction Per HipSatisfied106 number of participants
Patients With Serum Cobalt LevelsPatient Satisfaction Per HipUnsatisfied0 number of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026