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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
History of Changes
  Purpose

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.

Condition
Arthropathy of Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Dislocation [ Time Frame: 12 month postop ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 277
Study Start Date: May 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.
  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients indicated for total hip arthroplasty

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103882

Locations
Korea, Republic of
Hallym University Hospital
Anyang, Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Korea, Republic of
Murup Hospital
Masan, Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Biomet, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01103882     History of Changes
Other Study ID Numbers: KR1
Study First Received: April 13, 2010
Last Updated: July 9, 2014
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015