NCT00561600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed
Last Updated

August 9, 2017

Status Verified

June 1, 2017

Enrollment Period

5.2 years

First QC Date

November 20, 2007

Results QC Date

February 5, 2014

Last Update Submit

July 10, 2017

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

Hip arthroplastyAcetabular cup replacementAcetabulum arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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"

    24-month interval.

Secondary Outcomes (27)

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

    24 months

  • Harris Hip Pain Sub Score at 24 Months

    24 months

  • Harris Hip Function Score at 24 Months

    24 months

  • Analysis of Metal Ion Release - Serum Cobalt

    Pre-operative

  • Analysis of Metal Ion Release - Serum Chromium

    pre-operative

  • +22 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

ASR™-XL Modular Acetabular Cup System stem

Device: ASR™-XL Modular Acetabular Cup System

B

ACTIVE COMPARATOR

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

Device: Pinnacle™ acetabular shell

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.

Also known as: Acetabular cup replacement
A
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.

Also known as: Acetabular cup replacement
B

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Desert Orthopaedics

Rancho Mirage, California, 92270, United States

Location

Resurgens Orthopaedics

Cumming, Georgia, 30041, United States

Location

Illinois Bone and Joint Institute

Morton Grove, Illinois, 60053, United States

Location

Spectrum Health Hospital Research

Grand Rapids, Michigan, 49503-2550, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Eastern Oklahoma Orthopedic Center

Tulsa, Oklahoma, 74136, United States

Location

Orthopaedic Specialists of Austin

Austin, Texas, 78705, United States

Location

Valley Orthopaedic Associates

Renton, Washington, 98055-5791, United States

Location

Limitations and Caveats

At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred.

Results Point of Contact

Title
Dave Whalen Clinical Portfolio Leader
Organization
DePuy Orthopaedics
dwhalen@its.jnj.com
574-372-7028

Study Officials

  • Dave Whalen, BS, DC

    DePuy Orthopaedics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

November 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 9, 2017

Results First Posted

May 7, 2014

Record last verified: 2017-06

Locations

US(8)