Prosthesis LooseningNCT02237482
Investigating Proximal Migration in Trabecular Metal Cups Used In Acetabular Revision Surgery
A study testing Trilogy cup, Trabecular metal cup (TM) and ZCA cup in people with Prosthesis Loosening, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Prosthesis Loosening
- What is being tested?
- Trilogy cup, Trabecular metal cup (TM) and ZCA cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with a loose acetabular component, undergoing revision
Who cannot join
- Patient not able to understand the intention of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?
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.
Read the 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
- Being tested
- Trilogy cup, Trabecular metal cup (TM), ZCA cup
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trilogy cupDevice
Trabecular metal cup (TM)Device
ZCA cupDevice
| Study group | Role | What they receive |
|---|---|---|
| Small periacetabular bone defects | Experimental | Patients with cup loosening and small periacetabular bone defects Receives: Device: Trilogy cup; Device: Trabecular metal cup (TM) |
| Large periacetabular bone defects | Experimental | Patients with cup loosening and large periacetabular bone defects Receives: Device: Trabecular metal cup (TM); Device: ZCA cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 month postoperatively.
Secondary outcomes (1)
Patient reported outcome measures
Harris Hip Score
Measured: first two years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJul 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prosthesis LooseningStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maziar Mohaddes Ardebili, Sahlgrenska University Hospital
- Investigators
- Johan Kärrholm, Professor, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237482
- Sponsor's protocol ID
- 539-06
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15990104Cuckler 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.
PubMed 12068428Lakstein 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.
PubMed 19277803Schreurs 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.
PubMed 19721038
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Trabecular Metal Cup Associated With Lower Risk of Aseptic Loosening in Acetabular Revision Surgery?
- ClinicalTrials.gov ID
- NCT02237482
- Acronym / sponsor ID
- 539-06
- Conditions
- Prosthesis Loosening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small periacetabular bone defects | Experimental | Device: Trilogy cup, Device: Trabecular metal cup (TM)Patients with cup loosening and small periacetabular bone defects |
| Large periacetabular bone defects | Experimental | Device: Trabecular metal cup (TM), Device: ZCA cupPatients with cup loosening and large periacetabular bone defects |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a loose acetabular component, undergoing revision
Key exclusion criteria (1 listed)
- Patient not able to understand the intention of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trilogy cup | Device | Small periacetabular bone defects |
| Trabecular metal cup (TM) | Device | Large periacetabular bone defects, Small periacetabular bone defects |
| ZCA cup | Device | Large periacetabular bone defects |
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.
1 secondary outcome
Patient reported outcome measures
Time frame: first two years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Background: PubMed 15990104Borlin 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.
- Background: PubMed 12068428Cuckler 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.
- Background: PubMed 19277803Lakstein 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.
- Background: PubMed 19721038Schreurs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Kärrholm, Professor study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trilogy cup, Trabecular metal cup (TM) and ZCA cup in people with Prosthesis Loosening, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal migration measured with RSA (time frame: 24 month postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237482, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.