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

Not Applicable

Completed

• Conditions: Prosthesis Loosening
• Interventions: Device: Trabecular metal cup (TM); Device: Trilogy cup; Device: ZCA cup

• Registration Number: NCT02237482
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Large periacetabular bone defects	ZCA cup	Patients with cup loosening and large periacetabular bone defects
Large periacetabular bone defects	Trabecular metal cup (TM)	Patients with cup loosening and large periacetabular bone defects
Small periacetabular bone defects	Trilogy cup	Patients with cup loosening and small periacetabular bone defects
Small periacetabular bone defects	Trabecular metal cup (TM)	Patients with cup loosening and small periacetabular bone defects

Primary Outcome Measures

Name	Time	Method
Proximal migration measured with RSA	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 Outcome Measures

Name	Time	Method
Patient reported outcome measures	first two years postoperatively	Harris Hip Score

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden