Primary Total Hip ReplacementNCT02635581
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
A study testing Delta TT acetabular cup in people with Primary Total Hip Replacement, run by Limacorporate S.p.a at 4 sites in Italy.
Trial summary
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Total Hip Replacement
- What is being tested?
- Delta TT acetabular cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesItaly
- Study dates
- Dec 2008to Dec 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI< 40 kg/m2
- Indication suitable to the implantation of Delta TT acetabular cup (First implant)
- Idiopathic osteoarthritis
- Avascular necrosis
- Post-traumatic arthritis
- Presence of sufficient periacetabular bone stock
- Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
- Written informed consent
Who cannot join
- Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
- Patients aged 76 or older
- Haemophilic disease
- Femur neck fracture
- Insulin Dependent Diabetes Mellitus (IDDM)
- Severe kidney failure (grade 4)
Show all 15Show fewer
- Not responder Hypo- or Hyperthyroidism
- Paget's disease
- Tumours
- Active or suspicious infections
- Neurosensory deficits or neuromuscular diseases
- Severe and impairing vascular diseases
- Known incompatibility or allergy to products materials
- Woman with pregnancy or childbearing capacity or breast-feeding
- Subjects already enrolled in other clinical trials
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
Cona, Ferrara, 44124
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica II
Torino, 10126
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica I
Torino, 10126
Azienda Ospedaliero-Universitaria di Udine, Santa Maria della Misericordia
Udine, 33100
About this study
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.
- Conditions
- Primary Total Hip Replacement
- Being tested
- Delta TT acetabular cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta TT acetabular cupDevice
| Study group | Role | What they receive |
|---|---|---|
| DELTA TT | Experimental | Not described Receives: Device: Delta TT acetabular cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
Measured: From baseline to 5 year Follow-up
Secondary outcomes (2)
Harris Hip Score (HHS)
Measured: From baseline to 5 year Follow-up
SF-36 score
Measured: From baseline to 5 year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ReplacementStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leo Massari, Principal investigator, Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635581
- Sponsor's protocol ID
- TT-01
- Status last verified
- Mar 2016
- First submitted
- 15 Dec 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
- ClinicalTrials.gov ID
- NCT02635581
- Acronym / sponsor ID
- TT-01
- Conditions
- Primary Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2015 (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.
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DELTA TT | Experimental | Device: Delta TT acetabular cup |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI< 40 kg/m2
- Indication suitable to the implantation of Delta TT acetabular cup (First implant)
- Idiopathic osteoarthritis
- Avascular necrosis
- Post-traumatic arthritis
Key exclusion criteria (15 listed)
- Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
- Patients aged 76 or older
- Haemophilic disease
- Femur neck fracture
- Insulin Dependent Diabetes Mellitus (IDDM)
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 |
|---|---|---|
| Delta TT acetabular cup | Device | DELTA TT |
Primary outcome
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
Time frame: From baseline to 5 year Follow-up
2 secondary outcomes
Harris Hip Score (HHS)
Time frame: From baseline to 5 year Follow-up
SF-36 score
Time frame: From baseline to 5 year Follow-up
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 2 Mar 2016.
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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.
Leo Massari principal investigator
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta TT acetabular cup in people with Primary Total Hip Replacement, run by Limacorporate S.p.a at 4 sites in Italy.
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 8 inclusion and 15 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan (time frame: From baseline to 5 year Follow-up). 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 2 Mar 2016.