Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery
Primary Purpose
Prosthesis Loosening
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Trilogy cup
Trabecular metal cup (TM)
ZCA cup
Sponsored by
About this trial
This is an interventional treatment trial for Prosthesis Loosening
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
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Small periacetabular bone defects
Large periacetabular bone defects
Arm Description
Patients with cup loosening and small periacetabular bone defects
Patients with cup loosening and large periacetabular bone defects
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient reported outcome measures
Harris Hip Score
Full Information
NCT ID
NCT02237482
First Posted
September 4, 2014
Last Updated
September 10, 2014
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02237482
Brief Title
Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery
Official Title
Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Loosening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small periacetabular bone defects
Arm Type
Experimental
Arm Description
Patients with cup loosening and small periacetabular bone defects
Arm Title
Large periacetabular bone defects
Arm Type
Experimental
Arm Description
Patients with cup loosening and large periacetabular bone defects
Intervention Type
Device
Intervention Name(s)
Trilogy cup
Intervention Type
Device
Intervention Name(s)
Trabecular metal cup (TM)
Intervention Type
Device
Intervention Name(s)
ZCA cup
Primary Outcome Measure Information:
Title
Proximal migration measured with RSA
Description
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.
Time Frame
24 month postoperatively.
Secondary Outcome Measure Information:
Title
Patient reported outcome measures
Description
Harris Hip Score
Time Frame
first two years postoperatively
Other Pre-specified Outcome Measures:
Title
Re-revision due to aseptic loosening or radiographical loosening
Time Frame
minimum13 years postoperative
Title
EuroQol 5D
Time Frame
first two years postoperatively.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Kärrholm, Professor
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15990104
Citation
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.
Results Reference
background
PubMed Identifier
12068428
Citation
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.
Results Reference
background
PubMed Identifier
19277803
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.
Results Reference
background
PubMed Identifier
19721038
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.
Results Reference
background
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Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery
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