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

DePuy Synthes

Status: Completed

Conditions: Non-inflammatory Degenerative Joint Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00561600

04062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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265 participants in 2 patient groups

A

Active Comparator group

Description:

ASR™-XL Modular Acetabular Cup System stem

Treatment:

Device: ASR™-XL Modular Acetabular Cup System

B

Active Comparator group

Description:

Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.

Treatment:

Device: Pinnacle™ acetabular shell

Sponsor of this trial

Lead Sponsor

DePuy Synthes