Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

Osteoarthritis Clinical Trial

Official title:

Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02196792
• Other study ID #: project-ID S-20080151
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2009
• Est. completion date: May 1, 2030

Study information

• Verified date: June 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Primary idiopathic arthritis,

• Eligible for uncemented total hip arthroplasty

• 40 to70 years of age,

• Cup size of 54mm and above

Exclusion Criteria:

• Anteversion where non-standard stem can be used,

• Dysplasia (Center-edge angle of Wiberg < 20°),

• Malignant condition

• Prior radiotherapy

• Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),

• Complications during surgery (requiring screws in shell or femoral cerclage)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• E-Poly liner
E-Poly liner with a titanium cup
• ArComXL liner
ArComXL liner with a titanium cup
• 32 mm femoral head
Stem with a 32 mm CoCr femoral head
• 36 mm femoral head
Stem with a 36 mm CoCr femoral head

Locations

Country	Name	City	State
Denmark	Joseph Abdalla Nommesen El-Sahoury	Odense C	Syddanmark

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean head penetration from baseline to 5 year follow-up	Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up	From baseline to 5 years
Secondary	Mean cup migration form baseline to 5 year follow-up	Mean cup migration assessed using RSA from baseline to 5 year follow-up	From baseline to 5 years
Secondary	Mean change in clinical outcome score from baseline to 5 year follow-up	Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).	From baseline to 5 years