NCT01121146

Brief Summary

The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 5, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

13.3 years

First QC Date

May 10, 2010

Results QC Date

July 31, 2013

Last Update Submit

November 3, 2014

Conditions

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Keywords

OsteolysisPolyethyleneCrosslinked PolyethyleneTotal Hip ReplacementCT

Outcome Measures

Primary Outcomes (1)

  • Incidence of Clinically Significant Osteolysis

    The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.

    Minimum 9-year radiographic follow-up

Secondary Outcomes (4)

  • Polyethylene Wear

    Minimum 9-year radiographic follow-up

  • Rate of Reoperation

    10-year follow-up

  • Harris Hip Score

    Minimum 9-year follow-up

  • Patient Satisfaction

    Minimum 9-year follow-up

Study Arms (2)

Crosslinked Marathon polyethylene

ACTIVE COMPARATOR
Device: Total Hip Replacement

Standard Enduron polyethylene

ACTIVE COMPARATOR
Device: Total Hip Replacement

Interventions

Total Hip ReplacementDEVICE

Comparison of Marathon and Enduron polyethylene

Crosslinked Marathon polyethyleneStandard Enduron polyethylene

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (from original study)
  • Elective total hip replacement patient
  • (from 10-year follow-up)
  • Consented to the original study.
  • Received a Duraloc 100 cup with either a crosslinked Marathon or standard Enduron liner.
  • Received an AML/Solution or a Prodigy stem with 28mm cobalt chrome femoral head.

You may not qualify if:

  • (from original study)
  • None
  • (from 10-year follow-up)
  • Patient refused to consent to the 10-year follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Related Publications (2)

  • Leung SB, Egawa H, Stepniewski A, Beykirch S, Engh CA Jr, Engh CA Sr. Incidence and volume of pelvic osteolysis at early follow-up with highly cross-linked and noncross-linked polyethylene. J Arthroplasty. 2007 Sep;22(6 Suppl 2):134-9. doi: 10.1016/j.arth.2007.04.006. Epub 2007 Jul 27.

    PMID: 17823032RESULT

  • Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. doi: 10.1016/j.arth.2006.05.002.

    PMID: 16950057RESULT

MeSH Terms

Conditions

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteolysis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesBone ResorptionBone Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Results Point of Contact

Title
C. Anderson Engh, Jr., MD
Organization
AORI
research@aori.org
703-619-4411

Study Officials

  • Charles A. Engh, Sr., MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

  • C. Anderson Engh, Jr., MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

December 1, 1998

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 5, 2014

Results First Posted

November 5, 2014

Record last verified: 2014-11

Locations

US(1)