Clinical trial NCT01103882: Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 277
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for total hip arthroplasty

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.

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 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

Primary outcomes:
measure: Dislocation
timeFrame: 12 month postop
Secondary outcomes:
measure: Clinical Outcomes
timeFrame: 12 months, 18 months and 30 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Masan
country: Korea, Republic of
facility: Murup Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Murup Hospital, Masan, Korea
name: Woon-Hwa Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Yong-Chan Ha, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Yong-Kyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Hospital
name: Tae-Young Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: