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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Osteoarthritis, Hip
• Intervention / Treatment: Device: E-Poly liner; Device: 32 mm femoral head; Device: 36 mm femoral head; Device: ArComXL liner

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Joseph Abdalla Nommesen El-Sahoury

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E-Poly/32 mm; E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.	Device: E-Poly liner; E-Poly liner with a titanium cup; Device: 32 mm femoral head; Stem with a 32 mm CoCr femoral head
Active Comparator: E-Poly/36 mm; E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.	Device: E-Poly liner; E-Poly liner with a titanium cup; Device: 36 mm femoral head; Stem with a 36 mm CoCr femoral head
Active Comparator: ArComXL/32 mm; ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.	Device: 32 mm femoral head; Stem with a 32 mm CoCr femoral head; Device: ArComXL liner; ArComXL liner with a titanium cup
Active Comparator: ArComXL/36 mm; ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.	Device: 36 mm femoral head; Stem with a 36 mm CoCr femoral head; Device: ArComXL liner; ArComXL liner with a titanium cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Joseph Abdalla N. El-Sahoury, BSc.med, OUH Den Ortopædkirurgiske Forskningsenhed; Study Director: Ming Ding, Professor MD, Odense University Hospital, University of Southern denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2015
• Study Completion (Anticipated): May 1, 2030

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 20, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Joint Diseases; Musculoskeletal Diseases; Total hip arthroplasty; radiostereometric analysis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: project-ID S-20080151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED