This trial is active, not recruiting.

Condition arthropathy of hip
Sponsor Biomet, Inc.
Start date May 2010
End date August 2014
Trial size 277 participants
Trial identifier NCT01103882, INT.CR.LKR1.10


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

time frame: 12 month postop

Secondary Outcomes

Clinical Outcomes including Harris Hip Score, UCLA and WOMAC
time frame: 12 months, 18 months and 30 months

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
Principal investigator Woon-Hwa Jung, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..