Revision, JointNCT01183260
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
A study testing Trabecular Metal Revision Cup and Trabecular Metal Modular Cup in people with Revision, Joint, run by The Cleveland Clinic at 1 site in United States.
Trial summary
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Revision, Joint
- What is being tested?
- Trabecular Metal Revision Cup and Trabecular Metal Modular Cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 85 years
- Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
- Stable Health: At the time of surgery based on physical examination and medical history.
- Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
- Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Who cannot join
- Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
- Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
- Patients with history of radiation therapy.
- Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
- Patients with known diagnosis of renal disease.
- Patients with known diagnosis of osteoporosis.
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- Patients with history of steroid use in the hip joint region.
- Patients that have had a previous lumbar fusion.
- Patients whose surgical reconstruction required a pelvic cage or plate.
- Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
- Any female of childbearing potential who is pregnant or is planning on becoming pregnant during the study period (~2 years postoperative).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation.
Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA.
Read more
Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up.
Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components.
The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
Read the detailed description
none provided.
- Conditions
- Revision, Joint
- Being tested
- Trabecular Metal Revision Cup, Trabecular Metal Modular Cup
- Keywords
- revision total hip arthroplasty, bone mineral density, trabecular metal, DEXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular Metal Revision CupDevice
Revision of the acetabular cup
Trabecular Metal Modular CupDevice
Revision of the acetabular cup
| Study group | Role | What they receive |
|---|---|---|
| Trabecular Metal Revision Cup | Experimental | Patients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner. Receives: Device: Trabecular Metal Revision Cup |
| Trabecular Metal Modular Cup | Active comparator | Patients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner. Receives: Device: Trabecular Metal Modular Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprosthetic Bone Mineral Density (BMD) of Hip
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
Measured: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
Secondary outcomes (1)
Functional and General Health Outcome Assessments
Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems:
- SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health.
- SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health.
- HOOS Pain assesses pain in the hip
- HOOS Symptoms assesses symptoms such as stiffness in the hip
- HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.)
- HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.)
- HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life
Measured: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Revision, JointStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Wael Barsoum, The Cleveland Clinic
- Investigators
- Wael K Barsoum, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183260
- Sponsor's protocol ID
- ZIMM1007WB
- Other IDs
- 09-859
- Status last verified
- Oct 2017
- First submitted
- 13 Aug 2010
- Last updated
- 7 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)
- ClinicalTrials.gov ID
- NCT01183260
- Acronym / sponsor ID
- ZIMM1007WB
- Conditions
- Revision, Joint
- Keywords
- revision total hip arthroplasty, bone mineral density, trabecular metal, DEXA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Aug 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 7 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation.
Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA.
Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up.
Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components.
The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
Detailed description
none provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabecular Metal Revision Cup | Experimental | Device: Trabecular Metal Revision CupPatients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner. |
| Trabecular Metal Modular Cup | Active comparator | Device: Trabecular Metal Modular CupPatients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 - 85 years
- Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
- Stable Health: At the time of surgery based on physical examination and medical history.
- Patient is a revision total hip recipient, which requires a metal-backed hemispherical cup.
- Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.
Key exclusion criteria (11 listed)
- Patients undergoing bilateral surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery.
- Patients who do not plan to return to a Cleveland Clinic surgeon for follow-up visits (i.e. out of state/country patients who may choose to follow-up with a different surgeon).
- Patients with history of radiation therapy.
- Patients with known diagnosis of Brooker grade 3 or 4 HO (heterotopic ossification) in the hip joint region.
- Patients with known diagnosis of renal disease.
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 |
|---|---|---|
| Trabecular Metal Revision CupRevision of the acetabular cup | Device | Trabecular Metal Revision Cup |
| Trabecular Metal Modular CupRevision of the acetabular cup | Device | Trabecular Metal Modular Cup |
Primary outcome
Periprosthetic Bone Mineral Density (BMD) of Hip
Time frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
1 secondary outcome
Functional and General Health Outcome Assessments
Time frame: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wael K Barsoum, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabecular Metal Revision Cup and Trabecular Metal Modular Cup in people with Revision, Joint, run by The Cleveland Clinic at 1 site in United States.
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 5 inclusion and 11 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 7 Nov 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Periprosthetic Bone Mineral Density (BMD) of Hip (time frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2017.