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

Prosthesis Loosening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237482
• Other study ID #: 539-06
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: September 10, 2014
• Start date: July 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

Inclusion Criteria:

All patients with a loose acetabular component, undergoing revision

Exclusion Criteria:

Patient not able to understand the intention of the study

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prosthesis Loosening

Intervention

Device:
• Trilogy cup

• Trabecular metal cup (TM)

• ZCA cup

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Börlin N, Röhrl SM, Bragdon CR. RSA wear measurements with or without markers in total hip arthroplasty. J Biomech. 2006;39(9):1641-50. Epub 2005 Jun 28. — View Citation

Cuckler JM. Management strategies for acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4 Suppl 1):153-6. — View Citation

Lakstein D, Backstein D, Safir O, Kosashvili Y, Gross AE. Trabecular Metal cups for acetabular defects with 50% or less host bone contact. Clin Orthop Relat Res. 2009 Sep;467(9):2318-24. doi: 10.1007/s11999-009-0772-3. Epub 2009 Mar 10. — View Citation

Schreurs BW, Keurentjes JC, Gardeniers JW, Verdonschot N, Slooff TJ, Veth RP. Acetabular revision with impacted morsellised cancellous bone grafting and a cemented acetabular component: a 20- to 25-year follow-up. J Bone Joint Surg Br. 2009 Sep;91(9):1148-53. doi: 10.1302/0301-620X.91B9.21750. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-revision due to aseptic loosening or radiographical loosening		minimum13 years postoperative	No
Other	EuroQol 5D		first two years postoperatively.	No
Primary	Proximal migration measured with RSA	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.	24 month postoperatively.	No
Secondary	Patient reported outcome measures	Harris Hip Score	first two years postoperatively	No