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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196792

Enrollment

100

Registered

2014-07-22

Start date

2009-05-01

Completion date

2030-05-01

Last updated

2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Osteoarthritis, Hip

Keywords

Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty

Brief 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.

Interventions

DEVICEE-Poly liner

E-Poly liner with a titanium cup

DEVICEArComXL liner

ArComXL liner with a titanium cup

DEVICE32 mm femoral head

Stem with a 32 mm CoCr femoral head

DEVICE36 mm femoral head

Stem with a 36 mm CoCr femoral head

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Mean head penetration from baseline to 5 year follow-up	From baseline to 5 years	Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026