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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:
Zimmer Biomet
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT01103882
First received: April 13, 2010
Last updated: March 20, 2017
Last verified: July 2016
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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:
Further study details as provided by Zimmer Biomet:
Primary Outcome Measures:
- Dislocation [ Time Frame: 12 month postop ]
Secondary Outcome Measures:
- Clinical Outcomes including Harris Hip Score, UCLA and WOMAC [ Time Frame: 12 months, 18 months and 30 months ]
| Estimated Enrollment: | 277 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2017 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
- 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
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
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
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 |
More Information
| Responsible Party: | Zimmer Biomet |
| ClinicalTrials.gov Identifier: | NCT01103882 History of Changes |
| Other Study ID Numbers: |
INT.CR.LKR1.10 |
| Study First Received: | April 13, 2010 |
| Last Updated: | March 20, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
ClinicalTrials.gov processed this record on July 28, 2017