NCT04126421

Brief Summary

A prospective randomized controlled study evaluating the wear and migration of cemented acetabular sockets with third generation highly cross-linked vitamin E infused polyethylene and second generation highly crosslinked UHMWPE using Radiostereometric Analysis (RSA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

8.2 years

First QC Date

September 29, 2019

Last Update Submit

January 5, 2020

Conditions

Total Hip Arthroplasty (THA)

Keywords

Highly cross-linked polyethylene (HXLPE)Vitamin E infused polyethylene

Outcome Measures

Primary Outcomes (1)

  • Migration of prothesis components

    Migration of prothesis components using radiosterometric analysis of hip x-rays (RSA)

    5 years

Secondary Outcomes (4)

  • HHS (Patient reported outcome measure (PROMs))

    10 years

  • EQ-5D (Patient reported outcome measure (PROMs))

    10 years

  • WOMAC (Patient reported outcome measure (PROMs))

    10 years

  • VAS pain (Patient reported outcome measure (PROMs))

    10 years

Study Arms (2)

E1 Vitamin E infused HXLPE

ACTIVE COMPARATOR

E1 Vitamin E infused highly cross-linked polyethylene (HXLPE)

Device: Prosthesis component (acetabular cup) E1 cup

Marathon HXLPE

ACTIVE COMPARATOR

Marathon highly cross-linked polyethylene (HXLPE)

Device: Prosthesis component (acetabular cup) Marathon cup

Interventions

Prosthesis component (acetabular cup) E1 cupDEVICE

Semented acetabuar cup With E1 cup

Also known as: E1 cup
E1 Vitamin E infused HXLPE
Prosthesis component (acetabular cup) Marathon cupDEVICE

Semented acetabuar cup With Marathon cup

Also known as: Marathon cup
Marathon HXLPE

Eligibility Criteria

AgeUp to 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients under the age of 75 with primary or secondary arthrosis scheduled for total hip arthroplasty.

You may not qualify if:

  • a major anatomical deviation, immunosuppressive medication or a significant systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Orthopedic Surgery, Oslo Univsersity Hospital

Oslo, 0850, Norway

Location

Related Publications (15)

  • Digas G, Karrholm J, Thanner J, Malchau H, Herberts P. The Otto Aufranc Award. Highly cross-linked polyethylene in total hip arthroplasty: randomized evaluation of penetration rate in cemented and uncemented sockets using radiostereometric analysis. Clin Orthop Relat Res. 2004 Dec;(429):6-16.

    PMID: 15577460BACKGROUND

  • Kjærsgaard-Andersen 2010 Orthopaedics today

    BACKGROUND

  • The Norwegian Arthroplasty Register, 2009

    BACKGROUND

  • Garcia-Cimbrelo E, Munuera L. Early and late loosening of the acetabular cup after low-friction arthroplasty. J Bone Joint Surg Am. 1992 Sep;74(8):1119-29.

    PMID: 1400540BACKGROUND

  • Barrack RL, Folgueras A, Munn B, Tvetden D, Sharkey P. Pelvic lysis and polyethylene wear at 5-8 years in an uncemented total hip. Clin Orthop Relat Res. 1997 Feb;(335):211-7.

    PMID: 9020220BACKGROUND

  • Tarasevicius S, Robertsson O, Kesteris U, Kalesinskas RJ, Wingstrand H. Effect of femoral head size on polyethylene wear and synovitis after total hip arthroplasty: a sonographic and radiographic study of 39 patients. Acta Orthop. 2008 Aug;79(4):489-93. doi: 10.1080/17453670710015472.

    PMID: 18766481BACKGROUND

  • Harris WH, Muratoglu OK. A review of current cross-linked polyethylenes used in total joint arthroplasty. Clin Orthop Relat Res. 2005 Jan;(430):46-52. doi: 10.1097/01.blo.0000152603.58384.e9.

    PMID: 15662303BACKGROUND

  • Jacobs JJ, Roebuck KA, Archibeck M, Hallab NJ, Glant TT. Osteolysis: basic science. Clin Orthop Relat Res. 2001 Dec;(393):71-7. doi: 10.1097/00003086-200112000-00008.

    PMID: 11764373BACKGROUND

  • Doorn PF, Campbell PA, Worrall J, Benya PD, McKellop HA, Amstutz HC. Metal wear particle characterization from metal on metal total hip replacements: transmission electron microscopy study of periprosthetic tissues and isolated particles. J Biomed Mater Res. 1998 Oct;42(1):103-11. doi: 10.1002/(sici)1097-4636(199810)42:13.0.co;2-m.

    PMID: 9740012BACKGROUND

  • Campbell DG, Field JR, Callary SA. Second-generation highly cross-linked X3 polyethylene wear: a preliminary radiostereometric analysis study. Clin Orthop Relat Res. 2010 Oct;468(10):2704-9. doi: 10.1007/s11999-010-1259-y. Epub 2010 Feb 12.

    PMID: 20151231BACKGROUND

  • Ries MD, Pruitt L. Effect of cross-linking on the microstructure and mechanical properties of ultra-high molecular weight polyethylene. Clin Orthop Relat Res. 2005 Nov;440:149-56. doi: 10.1097/01.blo.0000185310.59202.e5.

    PMID: 16239799BACKGROUND

  • Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.

    PMID: 18594097BACKGROUND

  • Rohrl S, Nivbrant B, Mingguo L, Hewitt B. In vivo wear and migration of highly cross-linked polyethylene cups a radiostereometry analysis study. J Arthroplasty. 2005 Jun;20(4):409-13. doi: 10.1016/j.arth.2004.09.040.

    PMID: 16124954BACKGROUND

  • Rohrl SM, Li MG, Nilsson KG, Nivbrant B. Very low wear of non-remelted highly cross-linked polyethylene cups: an RSA study lasting up to 6 years. Acta Orthop. 2007 Dec;78(6):739-45. doi: 10.1080/17453670710014509.

    PMID: 18236179BACKGROUND

  • Malchau H. Revision total hip arthroplasty. Failure mechanisms and outcomes. Orthopedics. 1996 Sep;19(9):769-70. doi: 10.3928/0147-7447-19960901-17. No abstract available.

    PMID: 8887419BACKGROUND

Study Officials

  • Stephan M Röhrl, PhD, MD

    Division of Orthopedic Surgery, Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial (RCT). Randomized to either E1 semented cup or Marathon semented cup in total hip arthroplasty (THA).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Consultant Orthopedic Surgery

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 15, 2019

Study Start

April 1, 2011

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)