NCT02196792

Brief Summary

The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress81%
May 2009May 2030

Study Start

First participant enrolled

May 1, 2009

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Expected
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

6 years

First QC Date

July 14, 2014

Last Update Submit

June 17, 2022

Conditions

Osteoarthritis, HipOsteoarthritis

Keywords

Joint DiseasesMusculoskeletal Diseasesradiostereometric analysisTotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Mean head penetration from baseline to 5 year follow-up

    Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up

    From baseline to 5 years

Secondary Outcomes (2)

  • Mean cup migration form baseline to 5 year follow-up

    From baseline to 5 years

  • Mean change in clinical outcome score from baseline to 5 year follow-up

    From baseline to 5 years

Study Arms (4)

E-Poly/32 mm

ACTIVE COMPARATOR

E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.

Device: E-Poly linerDevice: 32 mm femoral head

E-Poly/36 mm

ACTIVE COMPARATOR

E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Device: E-Poly linerDevice: 36 mm femoral head

ArComXL/32 mm

ACTIVE COMPARATOR

ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.

Device: ArComXL linerDevice: 32 mm femoral head

ArComXL/36 mm

ACTIVE COMPARATOR

ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Device: ArComXL linerDevice: 36 mm femoral head

Interventions

E-Poly linerDEVICE

E-Poly liner with a titanium cup

E-Poly/32 mmE-Poly/36 mm
ArComXL linerDEVICE

ArComXL liner with a titanium cup

ArComXL/32 mmArComXL/36 mm
32 mm femoral headDEVICE

Stem with a 32 mm CoCr femoral head

ArComXL/32 mmE-Poly/32 mm
36 mm femoral headDEVICE

Stem with a 36 mm CoCr femoral head

ArComXL/36 mmE-Poly/36 mm

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary idiopathic arthritis,
  • Eligible for uncemented total hip arthroplasty
  • to70 years of age,
  • Cup size of 54mm and above

You may not qualify if:

  • Anteversion where non-standard stem can be used,
  • Dysplasia (Center-edge angle of Wiberg \< 20°),
  • Malignant condition
  • Prior radiotherapy
  • Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
  • Complications during surgery (requiring screws in shell or femoral cerclage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Abdalla Nommesen El-Sahoury

Odense C, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritisJoint DiseasesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

ArthritisRheumatic Diseases

Study Officials

  • Joseph Abdalla N. El-Sahoury, BSc.med

    OUH Den Ortopædkirurgiske Forskningsenhed

    PRINCIPAL INVESTIGATOR

  • Ming Ding, Professor MD

    Odense University Hospital, University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 22, 2014

Study Start

May 1, 2009

Primary Completion

May 1, 2015

Study Completion (Estimated)

May 1, 2030

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

DK(1)