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

NCT ID: NCT02237482

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Prosthesis Loosening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Small periacetabular bone defects

Patients with cup loosening and small periacetabular bone defects

Group Type: EXPERIMENTAL

Trilogy cup

Intervention Type: DEVICE

Trabecular metal cup (TM)

Intervention Type: DEVICE

Large periacetabular bone defects

Patients with cup loosening and large periacetabular bone defects

Group Type: EXPERIMENTAL

Trabecular metal cup (TM)

Intervention Type: DEVICE

ZCA cup

Intervention Type: DEVICE

Interventions

Trilogy cup

Intervention Type: DEVICE

Trabecular metal cup (TM)

Intervention Type: DEVICE

ZCA cup

Intervention Type: DEVICE

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

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maziar Mohaddes Ardebili

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Kärrholm, Professor

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

References

Borlin N, Rohrl SM, Bragdon CR. RSA wear measurements with or without markers in total hip arthroplasty. J Biomech. 2006;39(9):1641-50. doi: 10.1016/j.jbiomech.2005.05.004. Epub 2005 Jun 28.

Reference Type: BACKGROUND

PMID: 15990104 (View on PubMed)

Cuckler JM. Management strategies for acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4 Suppl 1):153-6. doi: 10.1054/arth.2002.32811.

Reference Type: BACKGROUND

PMID: 12068428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19277803 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19721038 (View on PubMed)

Other Identifiers

539-06

Identifier Type: -

Identifier Source: org_study_id