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

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ClinicalTrials.gov Identifier: NCT01103882
Recruitment Status : Active, not recruiting
First Posted : April 15, 2010
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:

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 or disease
Arthropathy of Hip

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.

Study Type : Observational
Estimated Enrollment : 277 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations
U.S. FDA Resources




Primary Outcome Measures :
  1. Dislocation [ Time Frame: 12 month postop ]

Secondary Outcome Measures :
  1. Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Zimmer Biomet
Investigators
Principal Investigator: Woon-Hwa Jung, M.D. Murup Hospital, Masan, Korea
Principal Investigator: Yong-Chan Ha, M.D., Ph.D. Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Principal Investigator: Yong-Kyun Lee, M.D., Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Tae-Young Kim, M.D. Hallym University Hospital

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01103882     History of Changes
Other Study ID Numbers: INT.CR.LKR1.10
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases