CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 264 enrolled
Drug / intervention
28 mm ceramic head on ceramic acetabular liner. +1 moredevice
Likely dose
28 mm ceramic head on ceramic acetabular liner or 28 mm ceramic head on polyethylene liner (total hip replacement)AI-extracted
Key inclusion· 7
  • ✓Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, post-traumatic arthritis, SCFE, pelvic fracture, or developmental dysplasia)
  • ✓X-ray confirms presence of non-inflammatory degenerative joint disease
  • ✓Age 20–75 at time of surgery
  • ✓Sufficient femoral and acetabular bone stock suitable for implants
Key exclusion· 19
  • ✕Previous prosthetic hip replacement device in the hip to be operated
  • ✕Previous Girdlestone procedure or surgical hip fusion in the hip to be operated
  • ✕Acute femoral neck fracture
  • ✕Above-knee amputation of contralateral and/or ipsilateral leg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00208507N/ACompleted
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Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis Study (28mm)

DePuy Orthopaedics·interventional·Posted Sep 21, 2005·Updated Nov 7, 2023

In Brief

A clinical study evaluating 28 mm ceramic head on ceramic acetabular liner. and 28 mm ceramic head on polyethylene liner for Joint Diseases. Completed, enrolled 264 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJoint Diseases
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartApr 1, 2003
Primary CompletionJan 5, 2012
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.8 years ago

Interventions

28 mm ceramic head on ceramic acetabular liner.device

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

28 mm ceramic head on polyethylene linerdevice

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