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RSA-Study of Cemented Hip Prostheses With Five Different Articulations

Primary Purpose

Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
charnley OGEE
Spectron Reflection CoCr
Spectron XLPE CoCr
Spectron Reflection Oxinium
Spectron XLPE CoCR
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring RSA

Eligibility Criteria

59 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • arthritis
  • dysplasia

Exclusion Criteria:

  • obesitas
  • charcots
  • paget
  • malignancy

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

2

3

4

5

1

Arm Description

articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized

articulation Spectron Ef CoCr/ Reflection All-Poly XLPE

articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized

articulation Spectron EF Oxinium/ Reflection XLPE

articulation Charnley/ Ogee

Outcomes

Primary Outcome Measures

wear

Secondary Outcome Measures

migration

Full Information

First Posted
June 16, 2008
Last Updated
February 27, 2017
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00698672
Brief Title
RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Official Title
A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare wear and migration of the following hip prostheses: Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput Spectron EF stem with XLPE cup and 28 mm CoCr caput Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput Spectron EF stem with XLPE cup and 28 mm Oxinium caput
Detailed Description
Detailed description in: Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients. Kadar T, Hallan G, Aamodt A, Indrekvam K, Badawy M, Skredderstuen A, Havelin LI, Stokke T, Haugan K, Espehaug B, Furnes O. J Orthop Res. 2011 Aug;29(8):1222-9. doi: 10.1002/jor.21389

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
RSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized
Arm Title
3
Arm Type
Active Comparator
Arm Description
articulation Spectron Ef CoCr/ Reflection All-Poly XLPE
Arm Title
4
Arm Type
Active Comparator
Arm Description
articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized
Arm Title
5
Arm Type
Active Comparator
Arm Description
articulation Spectron EF Oxinium/ Reflection XLPE
Arm Title
1
Arm Type
Active Comparator
Arm Description
articulation Charnley/ Ogee
Intervention Type
Device
Intervention Name(s)
charnley OGEE
Intervention Description
charnley OGEE
Intervention Type
Device
Intervention Name(s)
Spectron Reflection CoCr
Intervention Description
Spectron Reflection CoCr
Intervention Type
Device
Intervention Name(s)
Spectron XLPE CoCr
Intervention Description
Spectron XLPE CoCr
Intervention Type
Device
Intervention Name(s)
Spectron Reflection Oxinium
Intervention Description
Spectron Reflection Oxinium
Intervention Type
Device
Intervention Name(s)
Spectron XLPE CoCR
Intervention Description
Spectron XLPE CoCR
Primary Outcome Measure Information:
Title
wear
Time Frame
2 years
Secondary Outcome Measure Information:
Title
migration
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
59 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: arthritis dysplasia Exclusion Criteria: obesitas charcots paget malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kadar, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
50021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not planned

Learn more about this trial

RSA-Study of Cemented Hip Prostheses With Five Different Articulations

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