Clinical trial NCT00561600: Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Keywords: Hip arthroplasty
Acetabular cup replacement
Acetabulum arthroplasty
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 265
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
timeFrame: 24-month interval.
Secondary outcomes:
measure: T-Test of Harris Hip Total Score Means at 24 Months
timeFrame: 24 months
measure: Harris Hip Pain Sub Score at 24 Months
timeFrame: 24 months
measure: Harris Hip Function Score at 24 Months
timeFrame: 24 months
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: Pre-operative
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: pre-operative
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: pre-operative
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: Pre-operative
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: 4 months post-operative
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: 4 months post operative
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: 4 months post-operative
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: 4 months post-operative
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: 12 months post-operative
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: 12 Months
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: 12 Months
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: 12 months
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: 24 months
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: 24 months
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: 24 months
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: 24 months
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: 36 months
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: 36 months
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: 36 months
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: 36 months
measure: Analysis of Metal Ion Release - Serum Cobalt
timeFrame: 48 months
measure: Analysis of Metal Ion Release - Serum Chromium
timeFrame: 48 months
measure: Analysis of Metal Ion Release - Erythrocyte Cobalt
timeFrame: 48 months
measure: Analysis of Metal Ion Release - Erythrocyte Chromium
timeFrame: 48 months
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Desert Orthopaedics
state: California
city: Cumming
country: United States
facility: Resurgens Orthopaedics
state: Georgia
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital Research
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Tulsa
country: United States
facility: Eastern Oklahoma Orthopedic Center
state: Oklahoma
city: Austin
country: United States
facility: Orthopaedic Specialists of Austin
state: Texas
city: Renton
country: United States
facility: Valley Orthopaedic Associates
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Dave Whalen, BS, DC
role: STUDY_DIRECTOR
References: