Clinical Trial: Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient reported outcome measures [ Time Frame: first two years postoperatively ]

Harris Hip Score


Original Secondary Outcome: Patient reported outcome measures [ Time Frame: first two years postoperatively ]

Harris Hip Score and EuroQol-5D


Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: September 4, 2014
Date Started: July 2006
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014