NCT00546598

Brief Summary

This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
terminated

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

January 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

8.3 years

First QC Date

October 17, 2007

Last Update Submit

November 29, 2021

Conditions

Non-inflammatory Joint DiseaseOsteoarthritisAvascular NecrosisCongenital Hip DysplasiaPost-traumatic Arthritis

Keywords

Total hip replacement, Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Survivorship

    5 years

Secondary Outcomes (3)

  • Study subject SF-12 health survey

    1, 2 ,3, 4 and 5 years

  • SF-12 Health survey and Subject Outcomes Questionnaire

    6, 7, 8, 9 and 10 years

  • Hip Function (using Harris Hip Score)

    6 weeks, 6 months and 1, 2, 3, 4, and 5 years

Study Arms (1)

Duraloc Option COC Hip

OTHER
Device: Total hip replacement/arthroplasty

Interventions

Total hip replacement/arthroplastyDEVICE

Hip replacement

Also known as: DURALOC® Option Ceramic-on-Ceramic Hip system
Duraloc Option COC Hip

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature
  • Provide informed consent
  • Sufficient acetabular and femoral bone stock to seat the prosthesis
  • Willing and able to return for follow-up as specified by the study protocol
  • Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12)
  • Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.

You may not qualify if:

  • Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc.
  • Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc.
  • Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation.
  • Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant.
  • Morbid obesity
  • Involvement in high levels of activity or participation in active sports
  • Involvement in heavy manual labor employment
  • Increased likelihood of falls due to concomitant illnesses or impairment
  • Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser
  • Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant
  • Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease)
  • Known presence of active metastatic or neoplastic disease
  • Known allergic reactions to implant materials (e.g. ceramic, metal)
  • Known history of tissue reactions to implant corrosion or implant wear debris
  • Disabilities of other joints that impedes evaluation (e.g. knees, ankles)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Memorial Hospital

Springfield, Illinois, 62781, United States

Location

St. John's Hospital

Springfield, Illinois, 62781, United States

Location

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisHip Dislocation, Congenital

Interventions

Arthroplasty, Replacement, HipArthroplasty

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Dave Whalen, BS, DC

    DePuy Orthopaedics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

January 1, 2006

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

US(6)