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

Not Applicable

Completed

Interventions: Device: ASR™-XL Modular Acetabular Cup System
Device: Pinnacle™ acetabular shell

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
A	ASR™-XL Modular Acetabular Cup System	ASR™-XL Modular Acetabular Cup System stem
B	Pinnacle™ acetabular shell	Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.

Primary Outcome Measures

Name	Time	Method
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes	24-month interval.	"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"

Secondary Outcome Measures

Name	Time	Method
T-Test of Harris Hip Total Score Means at 24 Months	24 months	T-Test of Harris Hip total score means at 24 months
Harris Hip Pain Sub Score at 24 Months	24 months	Mean Harris Hip Pain sub score
Analysis of Metal Ion Release - Serum Chromium	48 months	Serum Chromium
Harris Hip Function Score at 24 Months	24 months	Mean Harris Hip Function sub score at 24 months
Analysis of Metal Ion Release - Erythrocyte Chromium	48 months	Erythrocyte chromium
Analysis of Metal Ion Release - Erythrocyte Cobalt	48 months	Erythrocyte Cobalt
Analysis of Metal Ion Release - Serum Cobalt	48 months	Serum Cobalt

Locations (8): Resurgens Orthopaedics
🇺🇸
Cumming, Georgia, United States
Illinois Bone and Joint Institute
🇺🇸
Morton Grove, Illinois, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Valley Orthopaedic Associates
🇺🇸
Renton, Washington, United States
Eastern Oklahoma Orthopedic Center
🇺🇸
Tulsa, Oklahoma, United States
Spectrum Health Hospital Research
🇺🇸
Grand Rapids, Michigan, United States
Desert Orthopaedics
🇺🇸
Rancho Mirage, California, United States
Orthopaedic Specialists of Austin
🇺🇸
Austin, Texas, United States