Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Arthroplasty Complications Clinical Trial

Official title:

Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03692364
• Other study ID #: Protesteam_ceram
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2003
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2018
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

Inclusion Criteria:

• primary osteoarthritis

• secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)

Exclusion Criteria:

• inflammatory arthritis

• hip joint infection

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Device:
• Ceramic-on-ceramic uncemented hip arthroplasty

• Metal-on-polyethylene uncemented total hip arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Stryker Nordic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteolysis frequency change between 7 and 15 years	Osteolysis frequency (%) measured with computed tomography,	Change between 7 to 15 years after surgery
Primary	Osteolysis size change between 7 and 15 years	Osteolysis size (cm3) measured with computed tomography	Change between 7 and 15 years after surgery
Secondary	Articulation wear at 7 years	Articulation wear as measured with radiostereometry, mm/year	At 7 years after surgery
Secondary	Articulation wear at 15 years	Articulation wear as measured with radiostereometry, mm/year	15 years after surgery
Secondary	Implant fixation at 7 years	Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry	7 years after surgery
Secondary	Implant fixation at 15 years	Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry	At 15 years after surgery
Secondary	Clinical function at 7 years	Harris Hip Score (0-100)	7 years after surgery
Secondary	Clinical function at 15 years	Harris Hip Score (0-100)	15 years after surgery