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Clinical Trials/NCT02237482
NCT02237482
Completed
N/A

Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?

Sahlgrenska University Hospital, Sweden1 site in 1 country100 target enrollmentJuly 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prosthesis Loosening
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
100
Locations
1
Primary Endpoint
Proximal migration measured with RSA
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This study is intended to compare the proximal migration of the tantalum design (TM) with a cemented cup used in conjunction with bone allografting in cases with major bone loss. A group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design regarding risk of loosening and differences in clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and rotation of the revision cups.

Detailed Description

Acetabular component loosening is often associated with periacetabular bone loss. Different approaches are described to address the bone defects in acetabular revision surgery. Several authors have reported inferior results when uncemented Titanium alloys and older porous coated designs are used in acetabular revisions with significant bone loss. Cemented fixation of the revision cup with impaction bone grafting (BIG), introduced more than three decades ago has today a thorough documentation. The Tantalum designs, with inherent properties such as high volumetric porosity, low modulus of elasticity and high friction against the bone, have been suggested to improve the fixation of the acetabular component. Several authors have been reporting promising short- and medium-term results using the TM designs in acetabular revisions with large periacetabular bone defects. Proximal migration measured with radiostereometry (RSA) has been suggested to predict risk for late aseptic loosening in hip prosthesis surgery. This study was primarily to compare the proximal migration of the tantalum design with a cemented cup used in conjunction with bone allografting in cases with major bone loss. A group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design. RSA is used to accurately measure migration and rotation of the revision cups.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
December 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Maziar Mohaddes Ardebili

M.D.

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • All patients with a loose acetabular component, undergoing revision

Exclusion Criteria

  • Patient not able to understand the intention of the study

Outcomes

Primary Outcomes

Proximal migration measured with RSA

Time Frame: 24 month postoperatively.

All patients have been recruited (operated on) by end of December 2011. Our primary intention is to follow all patients a minimum of two years with RSA.

Secondary Outcomes

  • Patient reported outcome measures(first two years postoperatively)

Study Sites (1)

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