RSA-Study of Cemented Hip Prostheses With Five Different Articulations

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00698672
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 5
• Duration (Months): 151
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

1. Charnley monoblock 22.2mm caput and OGEE polyethylene acetabular component

2. Spectron EF stem with Reflection polyethylene cup and 28 mm CoCr caput

3. Spectron EF stem with XLPE cup and 28 mm CoCr caput

4. Spectron EF stem with Reflection polyethylene cup and 28 mm Oxinium caput

5. Spectron EF stem with XLPE cup and 28 mm Oxinium caput

Condition or Disease	Intervention/Treatment	Phase
Arthritis	Device: charnley OGEE; Device: Spectron Reflection CoCr; Device: Spectron XLPE CoCr; Device: Spectron Reflection Oxinium; Device: Spectron XLPE CoCR	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized RSA-Study of Cemented Hip Prostheses With Five Different Articulations
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jun 1, 2007
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 articulation Spectron EF CoCr/ Reflection All-Poly Eto-sterilized	Device: Spectron Reflection CoCr; Spectron Reflection CoCr
Active Comparator: 3 articulation Spectron Ef CoCr/ Reflection All-Poly XLPE	Device: Spectron XLPE CoCr; Spectron XLPE CoCr
Active Comparator: 4 articulation Spectron EF Oxinium/ Reflection All-Poly Eto-sterilized	Device: Spectron Reflection Oxinium; Spectron Reflection Oxinium
Active Comparator: 5 articulation Spectron EF Oxinium/ Reflection XLPE	Device: Spectron XLPE CoCR; Spectron XLPE CoCR
Active Comparator: 1 articulation Charnley/ Ogee	Device: charnley OGEE; charnley OGEE

Outcome Measures

Primary Outcome Measures

1. wear [2 years]

Secondary Outcome Measures

1. migration [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 59 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• arthritis

• dysplasia

Exclusion Criteria:

• obesitas

• charcots

• paget

• malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	50021

Sponsors and Collaborators

• Haukeland University Hospital

Investigators

• Principal Investigator: Thomas Kadar, PhD, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT00698672
• Other Study ID Numbers: 10642(NSD); 197.03(REK)
• First Posted: Jun 17, 2008
• Last Update Posted: Feb 28, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Haukeland University Hospital: RSA
• Additional relevant MeSH terms: Arthritis

Study Results

No Results Posted as of Feb 28, 2017