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OpenTrials
Active, Not Recruiting

NCT Number: NCT02196792

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joseph Abdalla Nommesen El-Sahoury

Odense C, Region Syddanmark, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

E-Poly liner

Device

E-Poly liner with a titanium cup

ArComXL liner

Device

ArComXL liner with a titanium cup

32 mm femoral head

Device

Stem with a 32 mm CoCr femoral head

36 mm femoral head

Device

Stem with a 36 mm CoCr femoral head

Primary outcomes

  1. Mean head penetration from baseline to 5 year follow-up

    Time frame: From baseline to 5 years

    Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up

Secondary outcomes

  1. Mean cup migration form baseline to 5 year follow-up

    Time frame: From baseline to 5 years

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

  2. Mean change in clinical outcome score from baseline to 5 year follow-up

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2030
First posted
Jul 22, 2014
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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