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Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
E-Poly liner
ArComXL liner
32 mm femoral head
36 mm femoral head
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Joseph Abdalla Nommesen El-Sahoury

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

E-Poly/32 mm

E-Poly/36 mm

ArComXL/32 mm

ArComXL/36 mm

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean cup migration form baseline to 5 year follow-up
Mean cup migration assessed using RSA from baseline to 5 year follow-up
Mean change in clinical outcome score from baseline to 5 year follow-up
Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).

Full Information

First Posted
July 14, 2014
Last Updated
June 17, 2022
Sponsor
Odense University Hospital
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02196792
Brief Title
Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement
Official Title
Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2009 (undefined)
Primary Completion Date
May 1, 2015 (Actual)
Study Completion Date
May 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis
Keywords
Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-Poly/32 mm
Arm Type
Active Comparator
Arm Description
E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
Arm Title
E-Poly/36 mm
Arm Type
Active Comparator
Arm Description
E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
Arm Title
ArComXL/32 mm
Arm Type
Active Comparator
Arm Description
ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
Arm Title
ArComXL/36 mm
Arm Type
Active Comparator
Arm Description
ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
Intervention Type
Device
Intervention Name(s)
E-Poly liner
Intervention Description
E-Poly liner with a titanium cup
Intervention Type
Device
Intervention Name(s)
ArComXL liner
Intervention Description
ArComXL liner with a titanium cup
Intervention Type
Device
Intervention Name(s)
32 mm femoral head
Intervention Description
Stem with a 32 mm CoCr femoral head
Intervention Type
Device
Intervention Name(s)
36 mm femoral head
Intervention Description
Stem with a 36 mm CoCr femoral head
Primary Outcome Measure Information:
Title
Mean head penetration from baseline to 5 year follow-up
Description
Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up
Time Frame
From baseline to 5 years
Secondary Outcome Measure Information:
Title
Mean cup migration form baseline to 5 year follow-up
Description
Mean cup migration assessed using RSA from baseline to 5 year follow-up
Time Frame
From baseline to 5 years
Title
Mean change in clinical outcome score from baseline to 5 year follow-up
Description
Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).
Time Frame
From baseline to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary idiopathic arthritis, Eligible for uncemented total hip arthroplasty 40 to70 years of age, Cup size of 54mm and above Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Abdalla N. El-Sahoury, BSc.med
Organizational Affiliation
OUH Den Ortopædkirurgiske Forskningsenhed
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Ding, Professor MD
Organizational Affiliation
Odense University Hospital, University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Joseph Abdalla Nommesen El-Sahoury
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

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