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

NCT01103882 | Completed

• 1 other identifier: INT.CR.LKR1.10
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 4

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.

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• Dislocation

  Number of dislocations

  12 month postop

Secondary Outcomes (1)

• Clinical Outcomes

  12 months, 18 months and 30 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients indicated for total hip arthroplasty

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Hallym University Hospital

Anyang, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Murup Hospital

Masan, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)