NCT00208507

Brief Summary

The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

February 16, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2012

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

8.8 years

First QC Date

September 13, 2005

Results QC Date

January 21, 2011

Last Update Submit

November 2, 2023

Conditions

Joint Diseases

Keywords

Joint DiseasesNon-Inflammatory Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Total Score

    The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.

    The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)

Secondary Outcomes (1)

  • Complication Rates

    The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)

Study Arms (2)

Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System

ACTIVE COMPARATOR

Total hip replacement with a 28 mm ceramic head and liner.

Device: 28 mm ceramic head on ceramic acetabular liner.

Pinnacle™ Acetabular Cup with Marathon® Polyethylene

ACTIVE COMPARATOR

Total hip replacement with 28 mm ceramic head with a polyethylene liner.

Device: 28 mm ceramic head on polyethylene liner

Interventions

28 mm ceramic head on ceramic acetabular liner.DEVICE

Total hip replacement with 28 mm ceramic head on ceramic liner articulation

Also known as: Delta Ceramax™ 28 mm Ceramic-on-Ceramic Acetabular Cup
Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System
28 mm ceramic head on polyethylene linerDEVICE

Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.

Also known as: Detla Ceramax 28 mm ceramic femoral head and Marathon polyethylene liner.
Pinnacle™ Acetabular Cup with Marathon® Polyethylene

Eligibility Criteria

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

You may qualify if:

  • Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia.
  • X-ray evaluation confirms the presence of NIDJD
  • Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants.
  • Individuals 20 to 75 years of age at the time of surgery
  • Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study.
  • Harris Hip Score of 70 or lower
  • Pain at least Moderate

You may not qualify if:

  • Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
  • Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
  • Acute femoral neck fracture.
  • Above knee amputation of the contralateral and/or ipsilateral leg.
  • Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements.
  • Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled.
  • Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months.
  • Patients with a known allergy to metal (e.g. jewelry).
  • Skeletally immature patients (tibial and femoral epiphyses are not closed). Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.).
  • The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
  • Presence of known metastatic or neoplastic disease.
  • Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing, (e.g., muscular dystrophy, multiple sclerosis).
  • Conditions that may interfere with the total hip arthroplasty's survival or outcome, (e.g., Paget's disease, Charcot's disease).
  • Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol.
  • Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Cardinal Orthopaedic Institute

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Results Point of Contact

Title
Dave Whalen
Organization
DePuy Orthopaedics, Inc
DWhalen@its.jnj.com
574-372-7028

Study Officials

  • Joel Politi, MD

    Cardinal Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

  • Douglas Dennis, MD

    Colorado Joint Replacement

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
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

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2003

Primary Completion

January 5, 2012

Study Completion

January 5, 2012

Last Updated

November 7, 2023

Results First Posted

February 16, 2011

Record last verified: 2023-10

Locations

US(2)