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

N/AActive Not RecruitingNCT02196792

Odense University Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Osteoarthritis, Hip Osteoarthritis

Interventions

E-Poly linerDEVICE

E-Poly liner with a titanium cup

ArComXL linerDEVICE

ArComXL liner with a titanium cup

32 mm femoral headDEVICE

Stem with a 32 mm CoCr femoral head

36 mm femoral head

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

Joseph Abdalla Nommesen El-Sahoury

Odense C, Region Syddanmark, Denmark

Outcomes

Primary Outcomes

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

Time frame: From baseline to 5 years

Secondary Outcomes

Mean cup migration form baseline to 5 year follow-up

Mean cup migration assessed using RSA from baseline to 5 year follow-up

Time frame: 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).

Time frame: From baseline to 5 years

Data from ClinicalTrials.gov

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