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

NCT00208442 | Completed Phase 4

• 1 other identifier: CT99/31
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Keywords

Hip; Cemented

Outcome Measures

Primary Outcomes (1)

• Evaluate the linear and volumetric wear at the three-year time point.

  10yrs post surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

Marathon™

ACTIVE COMPARATOR

Moderately cross-linked polyethylene liner in a modular acetabular component

Device: Marathon™

Enduron™

ACTIVE COMPARATOR

Standard UHMWPE polyethylene liner in a modular acetabular component

Device: Enduron

Interventions

Marathon™ DEVICE

Moderately cross-linked polyethylene liner in a modular acetabular component

Marathon™

Enduron DEVICE

Standard polyethylene liner in a modular acetabular component

Enduron™

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

University Otago, Wellington Medical School of Medicine

Wellington, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 18547784 RESULT

• 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.

  PMID: 20458640 RESULT

MeSH Terms

Conditions

Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2001
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2013
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

NZ (1)