NCT00764530

Brief Summary

Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
342

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

3 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, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

11.2 years

First QC Date

September 30, 2008

Last Update Submit

July 26, 2017

Conditions

Rheumatoid ArthritisOsteoarthritisPost-traumatic ArthritisAvascular Necrosis

Outcome Measures

Primary Outcomes (1)

  • Alumina/Alumina articulation will perform as well as the alumina/polyethylene.

    5 year

Study Arms (2)

Investigational

EXPERIMENTAL

CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.

Device: Alumina/Alumina

Control Device

ACTIVE COMPARATOR

Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.

Device: Standard

Interventions

Alumina/AluminaDEVICE

CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell

Investigational
StandardDEVICE

Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head

Control Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis.
  • Less than 70 on preoperative HHS score
  • Primary total hip replacement
  • Patient is likely to be available for evaluation for the duration of the study.

You may not qualify if:

  • Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor)
  • Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement.
  • Insufficient quality or quantity of bone resulting from conditions such as:
  • Cancer, where radiation has destroyed the available bonestock
  • Congenital dislocation
  • Metabolic bone disease of the upper femur or pelvis
  • Femoral osteotomy revision
  • Girdlestone revision
  • Active infection of the hip joint
  • Old or remote infection
  • Other conditions that lead to inadequate skeletal fixation
  • Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side)
  • Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study
  • Mental illness
  • Senility
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mark Newman, Inc.

Newport Beach, California, 92663, United States

Location

Charleston Orthopaedic Assoc.

Charleston, South Carolina, 29414, United States

Location

Advanced Orthopaedic Centers

Richmond, Virginia, 23294, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisOsteonecrosis

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

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

September 30, 2008

First Posted

October 2, 2008

Study Start

November 1, 2003

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

US(3)