A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement

A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon

The purpose of this study is to compare the performance and compare the wear characteristics of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be evaluated at regular intervals using clinical and x-ray assessments.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Collagen Disorders; Traumatic Femoral Fractures; Nonunion of Femoral Fractures
• Intervention / Treatment: Device: Marathon™; Device: Enduron

Detailed Description

The original protocol intended to perform clinical assessment using the Harris Hip Score, Merle D'Aubigne score and UCLA Activity Level Rating at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post-operative. Merle D'Aubigne score evaluation was removed per Amendment 2.

However, protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery. Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• New Zealand
  • Wellington, New Zealand
    • University Otago, Wellington Medical School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

i) Male or female subjects, aged between 45 and 75 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with non-inflammatory arthritis of the hip who require a primary hip arthroplasty and are considered by the Clinical Investigator to be suitable for a cemented femoral component and an uncemented acetabular component.

v) Subjects who have a Charnley C classification

vi) Subjects who have undergone a contralateral hip replacement within past 6 months

vii) Subjects with a poorly functioning contralateral hip replacement or one which has been identified as requiring revision

viii) The first hip replacement scheduled for subjects identified as requiring primary bi-lateral hip replacements which will not be conducted simultaneously (i.e. on the same day).

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Marathon™; Moderately cross-linked polyethylene liner in a modular acetabular component	Device: Marathon™; Moderately cross-linked polyethylene liner in a modular acetabular component
Active Comparator: Enduron™; Standard UHMWPE polyethylene liner in a modular acetabular component	Device: Enduron; Standard polyethylene liner in a modular acetabular component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the linear and volumetric wear at the three-year time point.	10yrs post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively	10yrs post surgery
Radiographic analysis	10yrs post surgery
Oxford Hip Score	10yrs post surgery
SF-12 for Mental and Physical well-being	10yrs post surgery

Collaborators and Investigators

• Sponsor: DePuy International

Publications and helpful links

General Publications

• Calvert GT, Devane PA, Fielden J, Adams K, Horne JG. A double-blind, prospective, randomized controlled trial comparing highly cross-linked and conventional polyethylene in primary total hip arthroplasty. J Arthroplasty. 2009 Jun;24(4):505-10. doi: 10.1016/j.arth.2008.02.011. Epub 2008 Jun 10.
• Mutimer J, Devane PA, Adams K, Horne JG. Highly crosslinked polyethylene reduces wear in total hip arthroplasty at 5 years. Clin Orthop Relat Res. 2010 Dec;468(12):3228-33. doi: 10.1007/s11999-010-1379-4.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2001
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Hip; Cemented
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Femoral Fractures; Necrosis; Fractures, Bone; Rheumatic Diseases; Collagen Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Methyclothiazide
• Other Study ID Numbers: CT99/31