The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty

Arthroplasty, Replacement, Hip Clinical Trial

— THA  

Official title:

The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098604
• Other study ID #: SNU 08-01
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2010
• Last updated: March 19, 2014
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.

The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.

The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• osteonecrosis of femoral head

• primary or secondary osteoarthritis of the hips

• femoral neck fracture

Exclusion Criteria:

• previous hemi- or total hip arthroplasty

• highly dislocated or severe ankylosed hip

• patients who are considered potentially unreliable or who may not reliably attend study visits

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• 32mm ceramic head group
we performed THA using 32mm ceramic head in this group.
• 28mm ceramic head group
we performed THA using 28mm ceramic head in this group.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	6 weeks	Yes
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	3 months	Yes
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	6 months	Yes
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	9 months	Yes
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	12 months	Yes
Primary	rate of dislocation in each head size	to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.	24 months	Yes
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	6 weeks	No
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	3 months	No
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	6 months	No
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	9 months	No
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	12 months	No
Secondary	clinical results using Harris Hip Score	to compare the clinical results such as pain, function, range of motion between both groups.	24 months	No