Skip to main content
OpenTrials
Completed

NCT Number: NCT01103882

Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

The primary objectives of this clinical study include:

* Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants. * Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing. * Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years. * Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthropathy of Hip

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Hospital, Anyang, South Korea

Loading trial locations.

About this study

This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ("THA") in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:

  • The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
  • The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
  • The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
  • Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
  • Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
  • The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suitable for primary Total Hip Replacement
  • Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
  • Osteoarthritis
  • Avascular necrosis
  • Legg Perthes
  • Rheumatoid Arthritis
  • Diastrophic variant
  • Fracture of the pelvis
  • Fused hip
  • Slipped capital epiphysis
  • Subcapital fractures
  • Traumatic arthritis
  • Patients aged over 20
  • Patients must be able to understand instructions and be willing to return for follow-up

Exclusion criteria

  • Absolute contraindications include: infection, sepsis, and osteomyelitis
  • Relative contraindications include:
  • uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  • osteoporosis,
  • metabolic disorders which may impair bone formation,
  • osteomalacia,
  • distant foci of infections which may spread to the implant site,
  • rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
  • vascular insufficiency, muscular atrophy, or neuromuscular disease.
  • pregnancy

Treatment and study plan

Primary outcomes

  1. Dislocation

    Time frame: 12 month postop

    Number of dislocations

Secondary outcomes

  1. Clinical Outcomes

    Time frame: 12 months, 18 months and 30 months

    Harris Hip Score, UCLA and WOMAC

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

Important dates

Study start
2010
Primary completion
2014
Study completion
2017
First posted
Apr 15, 2010
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.