Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

DePuy Orthopaedics265 enrolled

Overview

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

265

Conditions

Non-inflammatory Degenerative Joint Disease

Interventions

ASR™-XL Modular Acetabular Cup SystemDEVICE

The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.

Pinnacle™ acetabular shellDEVICE

The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is able to or capable of providing consent to participate in the clinical investigation. * Subject is between the ages of 20-75 years, inclusive. * Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD). * Subject has sufficient bone stock for the hip replacement device. * Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device. Exclusion Criteria: * Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation. * Subject with a known allergy to metal (e.g. jewelry). * Subject has inflammatory arthritis (e.g. rheumatoid arthritis). * Subject has active or recent joint sepsis. * Subject with marked atrophy or deformity in the upper femur. * Subject with a neuromuscular disease where the loss of musculature would affect functional outcome. * Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis). * Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery. * Subject with known, active metastatic or neoplastic disease. * Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser. * Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.

Locations (8)

Desert Orthopaedics

Rancho Mirage, California, United States

Resurgens Orthopaedics

Cumming, Georgia, United States

Illinois Bone and Joint Institute

Morton Grove, Illinois, United States

Spectrum Health Hospital Research

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes

"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months"

Time frame: 24-month interval.

Secondary Outcomes

T-Test of Harris Hip Total Score Means at 24 Months

T-Test of Harris Hip total score means at 24 months

Time frame: 24 months

Harris Hip Pain Sub Score at 24 Months

Mean Harris Hip Pain sub score

Time frame: 24 months

Harris Hip Function Score at 24 Months

Mean Harris Hip Function sub score at 24 months

Time frame: 24 months

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Time frame: Pre-operative

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Time frame: pre-operative

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte cobalt

Time frame: pre-operative

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte Chromium

Time frame: Pre-operative

Analysis of Metal Ion Release - Serum Cobalt

Data from ClinicalTrials.gov

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