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

Non-inflammatory Degenerative Joint Disease Clinical Trial

— ASR  

Official title:

A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561600
• Other study ID #: 04062
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: April 7, 2014
• Start date: November 2006
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis

Intervention

Device:
• ASR™-XL Modular Acetabular Cup System
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 shell
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.

Locations

Country	Name	City	State
United States	Orthopaedic Specialists of Austin	Austin	Texas
United States	Resurgens Orthopaedics	Cumming	Georgia
United States	Spectrum Health Hospital Research	Grand Rapids	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Illinois Bone and Joint Institute	Morton Grove	Illinois
United States	Desert Orthopaedics	Rancho Mirage	California
United States	Valley Orthopaedic Associates	Renton	Washington
United States	Eastern Oklahoma Orthopedic Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes	"Composite success: Revision free (life of study); No evidence of radiographic failure (life of study); Harris Hip score => 80 at 24 months"	24-month interval.	Yes
Secondary	T-Test of Harris Hip Total Score Means at 24 Months	T-Test of Harris Hip total score means at 24 months	24 months	No
Secondary	Harris Hip Pain Sub Score at 24 Months	Mean Harris Hip Pain sub score	24 months	No
Secondary	Harris Hip Function Score at 24 Months	Mean Harris Hip Function sub score at 24 months	24 months	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	Pre-operative	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	pre-operative	Yes
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte cobalt	pre-operative	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte Chromium	Pre-operative	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	4 months post-operative	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	4 months post operative	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte Cobalt	4 months post-operative	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte Chromium	4 months post-operative	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	12 months post-operative	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	12 Months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte Cobalt	12 Months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte Chromium	12 months	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	24 months	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	24 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte Cobalt	24 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte Chromium	24 months	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	36 months	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	36 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte cobalt	36 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte chromium	36 months	No
Secondary	Analysis of Metal Ion Release - Serum Cobalt	Serum Cobalt	48 months	No
Secondary	Analysis of Metal Ion Release - Serum Chromium	Serum Chromium	48 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Cobalt	Erythrocyte Cobalt	48 months	No
Secondary	Analysis of Metal Ion Release - Erythrocyte Chromium	Erythrocyte chromium	48 months	No