NCT00698672

Brief Summary

The purpose of this study is to compare wear and migration of the following hip prostheses:

  1. 1.Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component
  2. 2.Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput
  3. 3.Spectron EF stem with XLPE cup and 28 mm CoCr caput
  4. 4.Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput
  5. 5.Spectron EF stem with XLPE cup and 28 mm Oxinium caput

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

June 16, 2008

Last Update Submit

February 27, 2017

Conditions

Arthritis

Keywords

RSA

Outcome Measures

Primary Outcomes (1)

  • wear

    2 years

Secondary Outcomes (1)

  • migration

    2 years

Study Arms (5)

2

ACTIVE COMPARATOR

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

Device: Spectron Reflection CoCr

3

ACTIVE COMPARATOR

articulation Spectron Ef CoCr/ Reflection All-Poly XLPE

Device: Spectron XLPE CoCr

4

ACTIVE COMPARATOR

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

Device: Spectron Reflection Oxinium

5

ACTIVE COMPARATOR

articulation Spectron EF Oxinium/ Reflection XLPE

Device: Spectron XLPE CoCR

1

ACTIVE COMPARATOR

articulation Charnley/ Ogee

Device: charnley OGEE

Interventions

charnley OGEEDEVICE

charnley OGEE

1
Spectron Reflection CoCrDEVICE

Spectron Reflection CoCr

2
Spectron XLPE CoCRDEVICE

Spectron XLPE CoCr

3
Spectron Reflection OxiniumDEVICE

Spectron Reflection Oxinium

4

Eligibility Criteria

Age59 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arthritis
  • dysplasia

You may not qualify if:

  • obesitas
  • charcots
  • paget
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 50021, Norway

Location

Related Publications (1)

  • Johannessen HG, Hallan G, Kadar T, Lie SA, Lygre SHL, Fenstad AM, Haugan K, Hol PJ, Badawy M, Jonsson B, Indrekvam K, Aamodt A, Furnes O. Early cup migration and wear as predictors for later aseptic loosening: a secondary evaluation of a randomized controlled RSA trial on cemented hip arthroplasties with 18-year follow-up. Acta Orthop. 2025 Aug 15;96:618-624. doi: 10.2340/17453674.2025.44328.

    PMID: 40814981DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Thomas Kadar, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 17, 2008

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2017

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Not planned

Locations

NO(1)