NCT04322799

Brief Summary

A prospective randomized study comparing two types of cemented acetabular components, a highly-crosslinked polyethylene or conventional polyethylene in total hip arthroplasty. Primary outcome are component wear measured by RSA, secondary outcomes are migration and complications. Patients are evaluated 5 years postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

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

February 7, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2014

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

March 24, 2020

Last Update Submit

March 30, 2020

Conditions

Osteoarthritis, HipArthroplasty Complications

Keywords

osteoarthritistotal hip arthroplastymigrationwear

Outcome Measures

Primary Outcomes (1)

  • Magnitude of Polyethylene Wear

    The size of the femoral component penetration into the polyethylene measured in millimeters per year and the volumetric annual wear millimetres with radiostereometric (RSA) analysis of radiographs.

    0-5 years

Secondary Outcomes (2)

  • Magnitude of Cup Migration

    0-5 years

  • Surgical complications

    0-5 years

Study Arms (2)

Acetabular cup HXLPE (Intervention)

EXPERIMENTAL

Randomization to HXLPE acetabular component.

Procedure: Device: Randomization between prosthetic components

Acetabular cup Conventional PE (control)

EXPERIMENTAL

Randomization to Coventional PE as control group

Procedure: Device: Randomization between prosthetic components

Interventions

Device: Randomization between prosthetic componentsPROCEDURE

Patients are randomized between two types of cup components in total hip arthroplasty. Identical cups made of either highly-crosslinked polyethylene or conventional polyethylene.

Acetabular cup Conventional PE (control)Acetabular cup HXLPE (Intervention)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis
  • Age 50 years and above
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

You may not qualify if:

  • Rheumatoid Arthritis
  • Grossly abnormal hip anatomy (severe dysplasia)
  • Fracture sequelae
  • Patients who, as judged by the surgeon, are mentally incompetent or are reasonable unlikely to be compliant with the requirements of the study
  • Immune suppression or grave systemic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lycksele hospital

Lycksele, 921 37, Sweden

Location

Related Publications (10)

  • Digas G, Karrholm J, Thanner J, Herberts P. 5-year experience of highly cross-linked polyethylene in cemented and uncemented sockets: two randomized studies using radiostereometric analysis. Acta Orthop. 2007 Dec;78(6):746-54. doi: 10.1080/17453670710014518.

    PMID: 18236180BACKGROUND

  • D'Antonio JA, Manley MT, Capello WN, Bierbaum BE, Ramakrishnan R, Naughton M, Sutton K. Five-year experience with Crossfire highly cross-linked polyethylene. Clin Orthop Relat Res. 2005 Dec;441:143-50. doi: 10.1097/00003086-200512000-00024.

    PMID: 16330997BACKGROUND

  • Rajadhyaksha AD, Brotea C, Cheung Y, Kuhn C, Ramakrishnan R, Zelicof SB. Five-year comparative study of highly cross-linked (crossfire) and traditional polyethylene. J Arthroplasty. 2009 Feb;24(2):161-7. doi: 10.1016/j.arth.2007.09.015. Epub 2008 Mar 4.

    PMID: 18534491BACKGROUND

  • Kurtz SM, Hozack WJ, Purtill JJ, Marcolongo M, Kraay MJ, Goldberg VM, Sharkey PF, Parvizi J, Rimnac CM, Edidin AA. 2006 Otto Aufranc Award Paper: significance of in vivo degradation for polyethylene in total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:47-57. doi: 10.1097/01.blo.0000246547.18187.0b.

    PMID: 17031310BACKGROUND

  • 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

  • McKellop H, Shen FW, Lu B, Campbell P, Salovey R. Development of an extremely wear-resistant ultra high molecular weight polyethylene for total hip replacements. J Orthop Res. 1999 Mar;17(2):157-67. doi: 10.1002/jor.1100170203.

    PMID: 10221831BACKGROUND

  • Lerf R, Zurbrugg D, Delfosse D. Use of vitamin E to protect cross-linked UHMWPE from oxidation. Biomaterials. 2010 May;31(13):3643-8. doi: 10.1016/j.biomaterials.2010.01.076. Epub 2010 Feb 9.

    PMID: 20144479BACKGROUND

  • Bragdon CR, Greene ME, Freiberg AA, Harris WH, Malchau H. Radiostereometric analysis comparison of wear of highly cross-linked polyethylene against 36- vs 28-mm femoral heads. J Arthroplasty. 2007 Sep;22(6 Suppl 2):125-9. doi: 10.1016/j.arth.2007.03.009. Epub 2007 Jul 26.

    PMID: 17823030BACKGROUND

  • Skoldenberg OG, Rysinska AD, Chammout G, Salemyr M, Mukka SS, Boden H, Eisler T. A randomized double-blind noninferiority trial, evaluating migration of a cemented vitamin E-stabilized highly crosslinked component compared with a standard polyethylene component in reverse hybrid total hip arthroplasty. Bone Joint J. 2019 Oct;101-B(10):1192-1198. doi: 10.1302/0301-620X.101B10.BJJ-2019-0456.R2.

    PMID: 31564144BACKGROUND

  • Otten V, Wasterlund D, Lindbjorn J, Mertens C, Mukka S, Crnalic S, Nilsson KG. Evaluation of a new cemented highly cross-linked all-polyethylene cup: a prospective and randomised study assessing wear and fixation characteristics using radiostereometric analysis. Hip Int. 2022 Nov;32(6):779-786. doi: 10.1177/1120700021989991. Epub 2021 Feb 10.

    PMID: 33566703DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjell Nilsson, Professor

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Two different acetabular cups in total hip arthroplasty. No difference in surgical surgical technique and type of stem. The cup have the identical outlining.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

February 7, 2013

Primary Completion

December 4, 2014

Study Completion

June 30, 2019

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

On request

Shared Documents
CSR
Time Frame
Publication at 1 year after completion of the study during 2020.
Access Criteria
International scientific peer-reviewed journal

Locations

SE(1)