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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01103882
First received: April 13, 2010
Last updated: July 9, 2014
Last verified: May 2013

April 13, 2010
July 9, 2014
May 2010
August 2014   (final data collection date for primary outcome measure)
Dislocation [ Time Frame: 12 month postop ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01103882 on ClinicalTrials.gov Archive Site
Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture 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.

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:

  1. The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
  2. The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
  3. The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
  4. Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
  5. Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
  6. The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients indicated for total hip arthroplasty

Arthropathy of Hip
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
277
May 2015
August 2014   (final data collection date for primary outcome measure)

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:

    1. Osteoarthritis
    2. Avascular necrosis
    3. Legg Perthes
    4. Rheumatoid Arthritis
    5. Diastrophic variant
    6. Fracture of the pelvis
    7. Fused hip
    8. Slipped capital epiphysis
    9. Subcapital fractures
    10. 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:

    1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
    2. osteoporosis,
    3. metabolic disorders which may impair bone formation,
    4. osteomalacia,
    5. distant foci of infections which may spread to the implant site,
    6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
    7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
    8. pregnancy
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01103882
KR1
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Woon-Hwa Jung, M.D. Murup Hospital, Masan, Korea
Principal Investigator: Yong-Chan Ha, M.D., Ph.D. Chung-Ang University Hospital
Principal Investigator: Yong-Kyun Lee, M.D., Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Tae-Young Kim, M.D. Hallym University Hospital
Biomet, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP